Indero, formerly known as Innovaderm, is a Canadian research institute specializing in dermatology and rheumatology, positioning itself as a clinical trial delivery partner for imm
Biostatistician
Location
Canada
Posted
18 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Biostatistician
Indero
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.
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
Clinical Oncology Pharmacist
Mass General BrighamMass General Brigham connects a full spectrum of care across a system of academic medical centers, specialty and community hospitals, physician networks, a health insurance plan, l
Title: Clinical Oncology Pharmacist MGH Location: Boston United States Job Description: remote type Hybrid time type Part time job requisition id RQ4063612 Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Our graduating oncology pharmacy residents will stay on per diem to support vacancy in our team as well as planned upcoming parental leave to support our schedule Job Summary Summary<br>The Per-Diem Pharmacist is responsible for the optimization of drug therapy by identification, resolution, and prevention of drug related problems and improving therapeutic outcomes. Also responsible for providing patient care according to the laws and regulations governing pharmacists and the practice of pharmacy by the appropriate state and federal agencies. May be responsible for prescribing medications under specific collaborative drug therapy management agreements (CDTM).<br><br>Does this position require Patient Care?<br>No<br><br>Essential Functions<br>-Directs and coordinates the activities and delivery of pharmacy services. <br> -Supervises and verifies the accuracy of all work completed by support personnel during an assigned shift. <br> -Operates within the limits of pharmacy policy and procedures. <br> -Ensures compliance with target drug programs, formulary management, medication management initiatives, and adverse drug event monitoring programs. <br> -Documents and reports clinical interventions, medication errors, adverse drug events. <br> -Participates in department quality improvement efforts. <br> -Follows all policies, procedures, laws, and regulations set forth by the Board of Pharmacy and all other applicable regulatory agencies. <br> Qualifications Education Doctor of Pharmacy Pharmacy required Can this role accept experience in lieu of a degree? No Licenses and Credentials Pharmacist [State License] - Generic - HR Only required Massachusetts Controlled Substances Registration [MCSR - Massachusetts] - Massachusetts Department of Public Health preferred Experience Experience working as a pharmacist 2-3 years preferred Knowledge, Skills and Abilities - Extensive knowledge and ability in all areas of the department including: IV Admixtures, Drug Information, Ambulatory, Manufacturing, and Drug Distribution. - Attention to detail. - Demonstrate appropriate knowledge of principles of growth and development over the life span of the neonate, adolescent, adult, and geriatric patient Possess ability to assess patient data relative to age specific needs Provide care as described in the department's policies/procedures. - Works relatively independently. - Participates in department quality improvement efforts. - Participates in the training of medical, nursing and allied health professionals. - Must complete 20 continuing education credits per year to maintain license. - Familiarity with pharmacy practice settings, legal requirements and limitations, prescription information and calculations, drug identification and generic equivalents, drug manufacturing, packaging and labeling information, and proper drug handling and storage practices. Additional Job Details (if applicable) Physical Requirements - Standing Frequently (34-66%) - Walking Frequently (34-66%) - Sitting Occasionally (3-33%) - Lifting Frequently (34-66%) 35lbs+ (w/assisted device) - Carrying Frequently (34-66%) 20lbs - 35lbs - Pushing Occasionally (3-33%) - Pulling Occasionally (3-33%) - Climbing Rarely (Less than 2%) - Balancing Frequently (34-66%) - Stooping Occasionally (3-33%) - Kneeling Occasionally (3-33%) - Crouching Occasionally (3-33%) - Crawling Rarely (Less than 2%) - Reaching Frequently (34-66%) - Gross Manipulation (Handling) Frequently (34-66%) - Fine Manipulation (Fingering) Frequently (34-66%) - Feeling Constantly (67-100%) - Foot Use Rarely (Less than 2%) - Vision - Far Constantly (67-100%) - Vision - Near Constantly (67-100%) - Talking Constantly (67-100%) - Hearing Constantly (67-100%) Remote Type Hybrid Work Location 55 Fruit Street Scheduled Weekly Hours 0 Employee Type Per Diem Work Shift Rotating (United States of America) Pay Range - / Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
• Writes, reviews, tests, and maintains code to support analytic dataset development and statistical analyses, ensuring accuracy, efficiency, and reproducibility. • Implements data quality initiatives under the guidance of the Registry Lead to ensure accuracy, completeness, and reliability of datasets. • Works closely with the Registry Lead to ensure timely completion of deliverables and adherence to project deadlines. • Assists the Registry Lead in maintaining existing reports and developing new reports as needed. • Produces monthly analytic data cuts, monthly reports, and quarterly reports, ensuring accuracy, consistency, and alignment with reporting requirements. • Serves as an additional point of contact for assigned registries, proactively supporting colleagues by addressing registry-related questions on data structures, outputs, etc. • Provides support on ad hoc projects and analyses as needed. • Creates data pipelines for ingestion of external data sources and integration with clinical registry data to create combined datasets. • Compiles, analyzes and reports statistical data for various projects. • Carries out complex statistical analyses with supervision according to a statistical analysis plan. • Assists Biostatistical Team Lead in the development of new statistical methodology for measurement and analysis of data. • Assesses relevant literature as well as existing data, evaluates the quality of data used in reports and assists with preparation and distribution of periodic reports. • Prepares written reports and summarizes data for investigators with minimal supervision. • Makes original contributions to research projects, takes initiative in professional activities and beginning to be more independent in their statistical decision making. • Closely collaborates and participates in knowledge sharing with other statistical analysts.
Clinical Scientist Ultrasound
Siemens HealthineersWe pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Role Description Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. The Clinical Science Liaison will have responsibility for clinical and academic collaborations within the Clinical Science and Collaborations segment of the Ultrasound Organization. Research is focused upon driving evidence generation from collaborations, clinical trials, and enhancing partnerships with external key thought leaders and luminaries. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Clinical Science Liaison, you will be responsible for: - Scientific expertise for developing research collaborations. - Remain current with published literature and clinical results for strategic purposes. - Promote continuous dialogue with collaborators to identify opportunities for collaboration on research topics and to translate these into project proposals. - Provide scientific feedback and advice to internal and external partners regarding our technologies. - Work directly with collaboration partners and research staff at luminary academic institutes. - Compile data and write project results, while performing statistical analysis and using statistics to develop study endpoints, sample size, etc. - Provide oversight of investigator-initiated research studies. Collaboration Management: - Contribute to study development and start-up process including reviewing protocols, drafting of IRB packages, consent forms, designing and/or reviewing CRFs, writing collaboration contracts, executing collaboration contracts, preparing volunteer Informed Consent forms, developing study documents, organizing, and presenting at investigator meetings, while working with management on monitoring strategy. - Negotiating and finalizing contracts for execution with support from legal, regulatory and compliance. - Ensure that all study related documents are tracked, filed and reviewed, and complete according to SOPs, regulatory requirements and protocol. - Administrative and logistical tasks, including tracking, collecting, distributing, and filing study documentation. - Ensure collaborations are on track for site initiation, subject recruitment and enrollment, as well as close-out. - Clinical trial execution and monitoring. - Work with management team to define timelines of milestones, deliverables and data. - Design reports and metrics that are useful management tools for projects. - Adapt to collaboration archiving tools and work with cross-functional teams and tools to ensure payment of milestones and deliverables. - Monitor activities at clinical study sites to ensure adherence to GCP, ICH, SOPs, FDA guidelines, study protocols, and internal collaboration controls including compliance. Qualifications - Ph.D. or other doctorate degree in Cardiology, Imaging, epidemiology or related disciplines +3 years of relevant experience; master’s degree. - Expertise in Imaging. - Expertise in imaging, cardiology, radiology, procedures. - 5+ years of experience in working with clinical research experience in med tech industry, health care or pharmaceutical. - At least 4+ years of clinical monitoring experience or clinical trial experience. - Experience in working with clinical and academic research environments. - In-depth knowledge of clinical trials and the critical elements for success in clinical trials. - Knowledge of medical terminology, as well as knowledge of clinical research and scientific principles. Benefits - Medical insurance. - Dental insurance. - Vision insurance. - 401(k) retirement plan. - Life insurance. - Long-term and short-term disability insurance. - Paid parking/public transportation. - Paid time off. - Paid sick and safe time.
Role Description At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. You will act as a strategic clinical advisor, partnering with internal Solventum teams and key customers to drive best practices and deliver advanced education. You will lead priority customer engagements, provide escalated clinical and technical consultation, and support economic value discussions with evidence-based data. As a Peri-op Area Clinical Leader, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: - Acting as strategic advisor to internal Solventum teams on wound care clinical strategy and industry best practices - Collaborating with sales leadership to identify opportunities to educate and upskill teams and individuals on clinical or technical consultative practices - Presenting compelling data and clinical application during priority planned customer engagements - Building and maintaining relationships with key healthcare customers to ensure customer loyalty and satisfaction - Engaging alongside local teams to plan & lead comprehensive customer education events - Directly interacting with customers who require escalated consultation on clinical or technical on-label scenarios - Serving as a consultative partner to various internal business stakeholders on clinical and/or technical matters - Supporting economic objection handling with customers by articulating evidence-based clinical efficacy and the connection to economic value - Aiding in resource management for conversions/evaluations - Maintaining clinical/technical relevance through ongoing continuous learning and participation in professional associations - Understanding and translating current relevant industry standards (e.g., ERAS, AAMI) Qualifications - Bachelor’s Degree or higher AND 2 years of healthcare experience in a hospital, surgery center, or long-term care environment - OR High School Diploma/GED AND 4 years of healthcare experience in a hospital, surgery center, or long-term care environment - Experience with Microsoft Office applications (i.e. Excel, Power Point, Outlook) - Current, valid Driver’s License Requirements - Current certification(s): BSN, RN, CNOR - Strong understanding of clinical value drivers across hospital care areas and alternative sites of care - Excellent organizational and time management skills - Understanding of the principles of adult learning - Demonstrated analytical, problem solving, project management, and implementation skills - Proven ability to cultivate strong internal and external collaborative relationships - Experience with public speaking and technical presentations Benefits - Medical, Dental & Vision - Health Savings Accounts - Health Care & Dependent Care Flexible Spending Accounts - Disability Benefits - Life Insurance - Voluntary Benefits - Paid Absences - Retirement Benefits Company Description Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges.



