Indero

Role Description The Strategist, Patient Recruitment & Site Engagement works with the Associate Director, Patient Recruitment Strategies and Development and the Specialist, Multimedia & Recruitment in supporting patient recruitment strategies and site engagement. This role will be perfect for you if: - Have at least 2 years’ experience in patient recruitment strategies & site engagement - Have experience working with Patient Advocacy groups - Have strong organizational and communication skills More specifically, the Strategist, Patient Recruitment and Site Engagement must: - Develop the project level and site level recruitment strategy plan in collaboration with the Patient Recruitment Team. - Inform and train project team on recruitment strategy in collaboration with the Project Manager and/or CTM. - Participate in BD handover, Kick off Meeting, Investigator meeting. - Develop the site's recruitment plan study template and ensure customization of this plan with each site. - Monitor the progression of subject enrolment to ensure the target can be achieved and propose improvements in recruitment strategies, as necessary, in collaboration with the Project Manager/CTM and/or clinical team. - Collaborate with Strategist, Patient Recruitment to create recruitment models based on information obtained during feasibility, site initiation, actual recruitment performance. - Collaborate with Strategist, Patient Recruitment to create the enrolment tracker with recruitment projections using CTMS or other system/tracker. - Work with SSU and project manager to obtain updated recruitment projections from sites post activation to forecast LPI or propose new strategies for recruitment which may include increasing sites, adding additional advertisement initiatives, physician outreach, etc. - Assist the Project Manager on client’s request for recruitment and advertisement. - Interact directly with client to establish and gain client input on recruitment strategies and budgets. - Create and design image and script advertisements for studies, in respect of Media’s and appropriate ethics committee’s current guidelines. - When applicable, offer guidance to sites on ways to achieve their recruitment target using their advertisement budget. - Ensure that all project relevant documentation is sent for filing in eTMF and archiving. - Coordinate global advertisement IRB submission and approval process. Qualifications - BA/BS required, preferably in Communications or related field with 3 years relevant experience OR a high school diploma / DEC with 5 years relevant experience. - Minimum of 2 years of relevant work experience in the biotechnology, pharmaceutical or CRO industry. Requirements - Knowledge of good clinical practice, ICH standards and applicable regulations. - English spoken and written; Spanish or French an asset. - Experience in a research site environment an asset. - Experience managing Patient advocacy group an asset. - Experience in Patient recruitment strategies an asset. - Problem solving skills, good adaptability, versatile, and great attention to details. - Strong organizational, communication, problem-solving and multi-tasking skills. Benefits - Flexible work schedule / work schedule. - Home-based position. - Ongoing learning and development. Company Description Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Argentina.

Role Description The Project Director is responsible for oversight of the conduct of a program or portfolio of clinical studies or large global multicentered trials with large study budgets. The portfolio may comprise studies for specific customers, and/or a group of studies within the same therapeutic area or indication for more than one customer. The Project Director oversees Project Managers (PMs) who are managing projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or portfolio of projects. The Project Director leads the operational contribution to proposal development and business development activities at a project level with minimal oversight directly applying their therapeutic and project management expertise. This role will be perfect for you if: - You are looking to contribute your expertise to the growth of a specialized CRO. - You are a hands-on leader. - You have at least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management. - You have experience in dermatology or rheumatology trials is required. Responsibilities - Oversees a portfolio or program of projects and the Project Managers assigned to operationalize the awarded studies. - Ensures all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements. - Represents company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively. - Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations. - Oversees the management of the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. - Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. - Ensures and maintains an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio. - Applies study specific learning across assigned portfolio of studies/clients. - Leads and ensures consistency in contingency planning and risk mitigation strategies to ensure successful delivery. - May lead operational input to proposal development and pricing including proposed operations strategy. - Drives performance improvement, operational efficiencies and innovative strategies. - May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert. Qualifications - Bachelor of Science in a relevant discipline. - A Master’s degree is an asset. - PMP or PRINCE2 Certification is an asset. Requirements - At least 15 years industry experience and a minimum of 5 years at a CRO. - At least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management. - Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) is desirable. - Experience leading concurrent multi-centered, multinational phase III clinical trials including project budget financial tracking and forecasting. - Substantial experience in project supervision, mentoring and coaching project managers. - Substantial experience with business development tasks, such as development of proposals, client presentations, bid defense meetings, and the like. - Participation in mentoring and coaching of a representative number of project managers. - Dermatology or rheumatology experience is required. - Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Benefits - At Indero, you will work with brilliant and driven colleagues. - Our values are collaboration, innovation, reliability, and responsiveness. - We offer a stimulating work environment and attractive advancement opportunities. - Note that this opening is for a home-based position in Germany. - Regular travel, which may include overnight trips and/or international travel is required as part of this role. Company Description Indero is a contract research organization (CRO) specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Germany.

Role Description The Proposal Writer Specialist should ensure consistent preparation of the proposal document through the business process. The Proposal Writer Specialist will support the Business Development Team at the pre-contract phase as well as on ongoing commercial activities. As a Proposal Writer specialist, you will be responsible for responding to Request for information (RFI), developing and writing the scientific and technical content of study proposals, and will interact with multiple functional groups within the company to develop the best customized proposal content. This role will be perfect for you if: - You are rigorous, articulate and creative in developing and writing scientific and technical content of proposals. - Your scientific mind is as sharp as your written communication skills and impeccable English grammar and spelling. - You are passionate about writing and you love creating factual and convincing scientific proposals. Responsibilities - Participate in the proposal launch meetings to understand the scope of the proposal and plan the appropriate steps to meet the timelines to issue a complete proposal to our clients. - Be responsible to maintain and improve the proposal template. - Be responsible to maintain the repository of RFI questions and answers. - Create specific proposal content to: - Accurately reflect project specific strategy discussions. - Meet Indero's and client’s needs and expectations. - Ensure accuracy and appropriateness of text and attachments. - Adapt the proposal to the changing departmental service offering. - Complement internal expertise with appropriate therapeutic area and indication research to support proposal development. - Obtain the input from internal subject matter experts to bring added value to the proposal. - Reach out, if needed, to external MDs and KOLs to support the development of the proposal. - Coordinate the various subject matter experts’ input to address any required actions on time for tight proposal delivery timelines. - Proofread and edit proposals so that the content is direct, easy to read, and compelling, while maintaining technical accuracy, be responsible for compliance and quality of all proposal efforts. - Support proposal and contract managers (PCMs) with ongoing training for drafting of proposal text. - Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Qualifications - Bachelor's degree in science. Requirements - Minimum of 2 years of successful experience in clinical research in the biotechnology, pharmaceutical, or CRO industry, including excellent understanding of CRO operations and project management budget elements. - Experience with RFPs, RFIs, RFQs, etc. is an asset. - Excellent organizational skills and ability to work under the pressure of multiple deadlines. - Ability to lead meetings and confident to deal with internal and external stakeholders. Must be a team player. - Excellent English grammar, spelling, and composition as well as writing, editing, and oral communication. - Excellent interpersonal skills. - Must be able to write persuasive narrative material, draft error-free, timely proposals, and provide clear explanations of technical requirements. - Excellent knowledge of Word and PowerPoint applications. Benefits - Flexible work schedule. - Permanent full-time position. - Company benefits package. - Ongoing learning and development. - Home-based position.

Role Description The Clinical Scientist is responsible for medical writing activities at Indero. The individual will author or contribute to development of clinical and regulatory documents (synopsis, study protocols, statistical analysis plans, clinical study reports), as well as scientific publications. This role will be perfect for you if: - You are a strong medical writer with demonstrated ability to produce high-quality scientific documents to support clinical research. - You enjoy learning continuously and keeping yourself informed. - Having an impact within a growing company with momentum motivates you. Responsibilities - Is accountable for own medical writing deliverables, including quality, stakeholder communication, resolution of project issues, and timeline management. - Collaborates to clinical development of Phase 1/First-in-Man studies, Proof of Concept (POC) trials, Phase 2b – 3 studies, and Phase 4/registry trials. - Contributes to study design and writes/reviews clinical study protocols/amendments. - Reviews informed consent/assent forms, study reference manuals, statistical analysis plans, and mock shells of statistical tables/figures/listings. - Reviews, analyzes, and interprets study data based upon scientific expertise and industry standard practices. - Writes/reviews narratives and clinical study reports. - Prepares scientific abstracts, posters, and manuscripts. - Performs on-line literature searches. - Provides documents with high quality in terms of scientific content, organization, clarity, accuracy, format and consistency. - May perform quality control review of documents prepared by other team members. - Participates in process improvement efforts of the department. Qualifications - MSc in life sciences; PhD is an asset. - Experience in writing clinical / regulatory documents such as study protocols and clinical study reports. - Experience analyzing and reporting on study data. - Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. - Good knowledge of drug development process. - Advanced English writing skills; strong English communication skills; French is an asset. - Strong proficiency of Word. - Ability to handle varied and multiple tasks, organize own work, and prioritize workload. - Has excellent attention to detail. - Client-focused attitude. - Quick learner, good adaptability, and versatile. Benefits - Flexible work schedule. - Permanent full-time position. - Ongoing learning and development. Company Description Indero, formerly Innovaderm, is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Canada.

Role Description Reporting to the Manager, Medical Monitoring, Medical Affairs, the Medical Monitor Associate provides medical, scientific, and administrative support to the medical monitoring team in their study level, department level, and cross-functional level activities. The Medical Monitor Associate will primarily assist with the daily tasks related to medical oversight in clinical trials. This role will be perfect for you if: - You have experience in clinical trials and are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project. - You are a dermatologist who skillfully balances the strict requirements of clinical research protocols with the realities of clinical trials. - You are able to interpret high volumes of data and situations efficiently, and take position and advise as necessary. Responsibilities - Keep current on study protocol, study protocol amendments, Investigator’s Brochure (IB), additional safety information made available during the course of the study, and relevant clinical research guidelines involving the therapeutic indication. - Support Medical Monitoring plan development. - Attend meetings with Innovaderm project team members (PM, DM, stats, CRO), as required. - Enter medical queries in EDC after lead medical monitor completes the subject safety-related data listings review. - Support with coding listings of adverse events, medical history, and concomitant medications review to ensure all terms are coded properly. - Conduct photo review for studies under their responsibility. - Review efficacy scores and related data. - Support business development activities with proposal development and sales presentations. - Assist with drafting of standard operating procedures and working practices regarding Medical Monitoring activities. - Perform other related duties as assigned or requested by the Director, Scientific and Regulatory Affairs. - Maintain up to date study tracker, KPI tracker. - Develop and/or collect relevant medical monitoring team documentation, and track completion. - Send documents for eSignature and file documents in the study folder/SharePoint. - Develop content for project level medical indication training (for each study), IM, team trainings. - Coordinate team meetings and trainings. - Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Qualifications - Medical degree; board-certified dermatologist. Requirements - Minimum 1 year experience in CRO or pharmaceutical industry in clinical research; or in clinical trials as an investigator experience as medical monitor/medical reviewer/drug safety physician for clinical trials an asset. - Excellent knowledge of the drug development process. - Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus. - Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment. - Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities. - Excellent verbal and written communication skills as well as interpersonal skills. - Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. - Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Benefits - Flexible work schedule. - Permanent full-time position. - Ongoing learning and development. - Vacations. - Bonus structure plan.

Role Description The Project Coordinator I provides administrative and coordination support to the Project Management and Clinical Operations teams throughout various stages of clinical studies. This is an entry-level position, ideal for individuals beginning their career in clinical research. The incumbent works under close supervision to support project deliverables and ensure quality and compliance in study documentation. - Prepare, review, and submit essential clinical trial and regulatory documents required for site activation under supervision. - Assist with the collection, organization, and maintenance of site regulatory documents in CTMS and eTMF. - Track and update project timelines, site status, and study milestones in project tracking systems. - Support the project team with assembling, shipping, and reconciling Investigator Study Files (ISFs). - Assist with study start-up, maintenance, and close-out activities, ensuring proper documentation throughout the trial lifecycle. - Maintain project-related logs (e.g., ADI, training, site visit, and correspondence logs). - File and organize email correspondence and visit reports in the eTMF to ensure audit readiness. - Participate in internal project meetings and take meeting minutes as required. - Coordinate the completion and tracking of study-specific training and assist with SOLABS reconciliation. - Communicate with internal team members and occasionally external partners for follow-up on outstanding documentation. - Provide general administrative and logistical support to Project Coordinators, Project Managers, and Clinical Operations. - Adhere to SOPs, Good Clinical Practice (GCP), and regulatory guidelines to ensure compliance. Qualifications - College or bachelor’s degree. - Experience in clinical research or a CRO/pharma environment is an asset. - Proficiency in English (written and oral). - Good knowledge of Microsoft Office (Word, Excel, PowerPoint). - Strong attention to detail and organizational skills. - Demonstrates learning agility, adaptability, and the ability to manage multiple priorities. Benefits - Flexible work schedule / work schedule. - Home-based position. - Ongoing learning and development. Company Description Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. - Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. - Our full-service approach includes everything from protocol design and patient recruitment to trial monitoring and biometrics. - We provide biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. - With capabilities in North America, Europe, Asia Pacific, and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. - Indero is committed to providing equitable treatment and equal opportunity to all individuals.

Role Description The Human Resources Technician is responsible to provide support to the Human Resources Department with all aspects of the department including, but not limited to: - Recruitment - Training - Benefits administration - HR metrics - Employee lifecycle More specifically, the Human Resources Technician must: - Own, manage and maintain the Human Resource Management system (HRMS) data to ensure accuracy and availability throughout the employee lifecycles. - Support the Human Resources Business Partner with all HR-related documentation including employment agreements, annexes, communication to candidates, employment confirmation letters, leave of absence documentation, etc. - Ensure all HR-related documentation is complete, maintain employee files, and follow up on outstanding HR documents. - Support recruitment activities including job postings, translation, screening resumes, background and reference checks, and preparation of employment agreements. - Manage HR Inbox and respond to employee queries and concerns or escalate when appropriate. - Administer employee benefit programs, including health benefits, open enrollment, group pension plan, etc. - Collaborate with payroll on any time off reports, pay & benefits related queries. - Assist with reporting for payroll, absence tracking, and ad-hoc reporting. - Assist with the development and maintenance of training programs within the HR department. - Manage and improve key HR tools, processes, and workflows to keep the HR department running smoothly. - Participate in Human Resources projects and initiatives as assigned. - Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Qualifications - College Degree in Human Resources Management, Administration or equivalent. - Previous experience in Recruitment or Human Resources department will be considered an asset. - Bilingual in French and English, both written and spoken. - Good knowledge of MS Office (Excel, Word, and Outlook). - Experience working with an ATS and an HRIS system will be considered an asset. - Ability to work in a fast-paced and dynamic environment. - Autonomy and sense of initiative. - High degree of confidentiality and professionalism. - Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Benefits - Flexible work schedule. - Permanent full-time position. - Company benefits package. - Ongoing learning and development. - Home-based position. Company Description Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Canada.

Role Description The Senior Project Coordinator works with Project Managers, Clinical Trial Managers, Site Selection Team and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle. As a Senior Project Coordinator, you will take the lead to ensure timeframes, targets and the quality of the deliverables are in line with internal and external customer expectations. As a Senior member of the team, you work autonomously to ensure optimized site activation and maintenance and you may be asked to mentor junior project coordinators. This role will be perfect for you if: - You have a minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry. - You have proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment. - You have an interest in project administration and clinical research. - You want to have an impact in a fast-growing company. More specifically, the Senior Project Coordinator: - Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents. - Establishes site activation timelines with selected sites and coordinates activities to meet planned activation timelines. - Communicate with clinical sites during site start-up. - Collaborates with other functional departments to ensure alignment of activities to meet site activation targets. - Escalates to the Project Manager risks to site activation schedule. - Communicates directly with the study teams, external site staff, to ensure tasks and priorities are aligned to the defined study timelines. - Collects, reviews and files sites essential documents. - Ensures essential documentation is complete and of good quality to successfully first pass review for site activation. - Ensures that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management. - Collects and distributes documents from / to sites. - Produces meeting minutes from project meetings. - Maintains ADI log. - Assigns documents for internal project-specific training and coordinates training reconciliation and documentation. - May assist with drafting of study documents and study plans for clinical trials. - Acts as a main point of contact for all site correspondences for non-protocol related issues. - Assists sites with local ethics submissions. - Assist internal and external teams with access to study-specific systems. - Assist with initiating and maintaining study files. - Assist with assembling and shipping the Investigator’s Study File. - Maintains project timeline dates, enrolment tracking tools, and study material inventory. - Prepares shipments of study supplies to clinical sites, when applicable. - Assists with preparation of Investigators’ Meeting. - Distributes study correspondence to sites. - Serves as in-house contact to support CRAs when traveling. - Reviews and reconciles investigators site and vendor payments. - Assists with project tracking activities and status reports preparation. - Participates in various administrative tasks as required to accomplish the goals of the project and the needs of the project team. - May support Health Authority inspection and pre-inspection activities. - May support audit preparation & Corrective Action / Preventative Action preparation for project related issues. - May perform project management duties on designated trials. - May mentor junior Project Coordinators and assist with onboarding activities. - May assist with process improvement and creation of training material within the Site Activation and Project Coordination department. Qualifications - Bachelor’s degree in a field relevant to clinical research or equivalent experience. - Specialized graduate diploma in drug development is an asset. Requirements - Minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry. - Proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment. - Good knowledge of essential documentation requirements for clinical trials. - Proficiency in English (written and oral) is required. - Bilingual French and English or fluency in another European or Asian language is an asset. - Excellent knowledge and competency in Word, Excel, and Power Point. - Ability to prioritize multiple assignments to meet deadlines. - Attention to detail. - Quick learner, good adaptability and versatile. - Strong organizational, communication, problem-solving and multi-tasking skills. - Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Benefits - Flexible work schedule. - Permanent full-time position. - Company benefits package. - Ongoing learning and development. Company Description Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Europe.

Role Description The Biostatistician will act as support or Lead Biostatistician on multiple phase 1 to 4 clinical trials, providing input into the statistical sections of protocols (incl. sample size calculation/validation), Risk-based Monitoring Plans, various Data Management (DM) documents, and statistical sections of clinical study reports (CSRs). The Biostatistician will also ensure the general financial health of clinical trials, develop Statistical Analysis Plans (SAP; incl. Table, Listing, and Figure [TLF] shells), and support teams of Statistical Programmers performing statistical analysis of clinical trial data. The Biostatistician will work collaboratively within Biostatistics study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Innovaderm’s standard operating procedures (SOPs) and processes. More specifically, the Biostatistician must: - Adhere and promote company organizational values and related expected behaviors. - Follow company SOPs and processes for all deliverables. - Ensure all trainings assigned to oneself are completed on time. - Act as Lead Biostatistician on multiple Phase 1 to 4 clinical trials by: - Acting as Biostatistics primary point of contact for Leads from other Innovaderm departments, Sponsors, and 3rd party vendors for clinical trials. - Being responsible for all statistical aspects of clinical trials. - Supporting teams of Statistical Programmers performing statistical analyses of clinical trials data. - Managing timelines of the deliverables of Biostatistics study teams for clinical trials. - Reviewing the scope of work and budget for Biostatistics study teams at initiation of clinical trials. - Proactively and promptly identifying out of scope (OoS) works throughout the course of clinical trials. - Providing Project Managers with budget estimates for OoS works and ensuring these budgets are included in Change Orders (COs). - Ensuring that the forecast of Biostatistics study teams’ budget is accurate at all times. - Performing revenue recognition of Biostatistics budgets monthly. - Monitoring monthly, project-to-date, and overall HPIs of clinical trials. - Review and provide input into statistical sections of protocols (incl., sample size calculations or validation). - Participate in the development of Risk-based Monitoring Plan for clinical trials. - Review and provide input into various DM documents (e.g., electronic Case Report Forms [eCRF], Data Validation Specifications [DVS], Data Transfer Agreements [DTAs], etc.) for clinical trials. - Support DM with data cleaning activities by programming, reporting, reviewing, and closing biostatistical data issues. - Develop Unblinding Plans, SAPs, and TLF Shells for clinical trials. - Perform (Lead) Biostatistician review of Clinical Data Interchange Standards Consortium (CDISC) Standard Data Tabulation Model (SDTM) trial domains. - Review and provide input into statistical sections of CSRs. - Act as Unblinded Support Biostatistician for clinical trials. - Conduct statistical analysis for Investigator Initiated Studies (IISs) and internal research and development (R&D) projects. - Contribute to the identification of future internal initiatives to increase efficiency/quality of Biostatistics activities/deliverables. - Keep abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements. - May also: - Contribute to the development/maintenance/validation of the statistical programming of ADAMs and TFLs for clinical trials. - Act as Unblinded Biostatistician by developing or reviewing Randomization Plans, Dummy Randomization Lists, and Final Randomization Lists. - Attend meetings outside of employee’s normal business hours. - Act as a Peer Biostatistician on multiple clinical trials. Qualifications - Master’s degree or PhD in Statistics, Biostatistics, or a related field with some applied biostatistics training relevant to clinical trials required. - At least 1 year of clinical trials experience in the Biotechnology, Pharmaceutical, and/or Contract Research Organization (CRO) industries required. - Good knowledge of drug development process, ICH guideline (including but not limited to, ICH E6(R2), E9, and E9(R1)), and relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations and guidelines preferred. - Significant exposure to clinical trial data, SAPs, and TLF Shells preferred. - Good knowledge of CDISC standards and guidelines an asset. - Good working knowledge of SAS for the purpose of analyzing clinical trial data preferred. - Very organized and detail-oriented, with effective project planning and time management skills. - Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. - Must be able to work independently and as part of a team. - Strong verbal and written communication skills in English; French an asset. Benefits - Permanent full-time position - Flexible schedule - Home-based position - Ongoing learning and development Company Description At Indero, formerly Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. Indero, formerly Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero, formerly Innovaderm continues to grow and expand in North America and Europe. Indero, formerly Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero, formerly Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero, formerly Innovaderm only accepts applicants who can legally work in Canada.

Role Description The Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Senior Statistical Programmer will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms [eCRFs], edit checks, etc.), support DM with data cleaning activities, use global SAS macros and participate in internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs. The Senior Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Innovaderm’s standard operating procedures (SOPs) and processes. More specifically, the Senior Statistical Programmer must: - Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time. - Act as a Lead Statistical Programmer on multiple single studies. - Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope. - Review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells. - Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician. - Develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Innovaderm and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT). - Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Innovaderm and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). - Develop/maintain/validate (as applicable) of SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Innovaderm and/or Sponsor' standards and interpretation of CDISC Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). - Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). - Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs. - Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs. - Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables. - Participate in internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables, including but not limited to development/improvement/validation of standard macros, templates, and programming standards and processes. - Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements. - May also mentor more junior Statistical Programmers. - Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Qualifications - Bachelor’s degree in Statistics, Computing Sciences or a related field; master’s degree an asset. - At least 5 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 4 years of Statistical Programming and 1 year acting as a Lead Statistical Programmer. - Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications. - Excellent working knowledge of SAS; SAS certification an asset. - Knowledge of XML programming an asset. - Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset. - Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. - Very organized and detail-oriented, with effective project planning and time management skills. - Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. - Must be able to work independently and as part of a team. - Strong verbal and written communication skills in English; French an asset. Benefits - Permanent full-time position - Flexible schedule - Home-based position - Ongoing learning and development Company Description At Indero, formerly Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. Indero, formerly Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero, formerly Innovaderm continues to grow and expand in North America and Europe. Indero, formerly Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero, formerly Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero, formerly Innovaderm only accepts applicants who can legally work in Argentina.