ClinChoice

Role Description Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Clinical Trial Administrator to join a pharmaceutical company. - Prepares/assembles study documentation, including submission package to Regulatory Authorities and Ethics Committees, study documents prepared through EDMS, reviews English texts and translations, and is in charge of formatting study documents, such as study protocols, clinical study reports, etc. - Responsible for electronic TMF set-up and maintenance during the study, oversight of filing documentation completeness, through ongoing quality checks and metrics, oversight of CRO filing activities in the eTMF. - Responsible for eTMF and paper TMF reconciliation after study completion. - Participates in the completion and review of Requests for Proposals sent to CROs in collaboration with the Clinical Project Manager. - Follows the CRO Awarding Process and handles the invoice process. - Provides input for budget development at Forecast, and Preclosing; checks monthly costs invoiced to the Sponsor based on planned study activities vs actual through our dedicated tool and ensures that invoices received are as expected; manages the Investigator Fees reconciliation and supports the Clinical Project Manager in all activities related to budget operations. - Organizes and participates in Kick Off Meetings, Study Design Meetings, and phone conferences with the CROs for continuous updates on clinical studies. May participate, if required, in the Investigator's Meetings and other study-specific meetings. - Assists with CRO oversight, and ensures that the trial complies with SOPs and all necessary quality standards. - Collaborates with the Clinical Project Manager with corrective and preventive actions, in case of deviations and following audits. - Reviews SOPs, if required. - Assists the eCTD team in the formatting of all documentation related to a clinical study, aimed at obtaining an electronic copy of the registration dossier. Qualifications - Bachelor's degree. - Experience in clinical research or the healthcare-related industry, including as a Clinical Trial Assistant. - Working knowledge of international regulatory and ICH-GCP guidelines. - Experience managing study budgets, study documentation, and TMFs is essential. - Experience with early-phase clinical trials (beneficial). - Experience working as part of a large team with proven ability to make an active contribution to the team's performance and teamwork. Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical devices, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. - Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. - Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built. - Close management and training is the core instrument to develop and maintain highly-qualified personnel. - The continuous training keeps the resources qualified in terms of competence and expertise. - ClinChoice is an equal opportunity employer, guided by diversity and inclusivity.

• Serve as study statistician or support statistician on Bronchiectasis or Hepatitis B programs • Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. • Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. • Responsible for assuring that data for statistical analyses are complete, accurate and consistent. • Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions. • Responsible for validity of analysis and alternative analysis strategies when unforeseen circumstances arise. • Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation. • Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings. • Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.

• Serve as study statistician or support statistician on Bronchiectasis or Hepatitis B programs • Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. • Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. • Responsible for assuring that data for statistical analyses are complete, accurate and consistent. • Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions. • Responsible for validity of analysis and alternative analysis strategies when unforeseen circumstances arise. • Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation. • Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings. • Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.

Role Description Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients. The Senior Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks. Main Job Tasks and Responsibilities: - Responsible for supporting the Programming deliveries of a clinical study or project. - Implements statistical programming aspects of the protocol and the clinical development program. - Ensures high quality is built into own deliverables and the quality delivered by other programmers. - Programs independently with high efficiency and quality. - Writes and/or implements specifications and oversees completeness of relevant documentation. - Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function. - Ensures compliance with standards and automation usage. - Plans and support team activities and tasks. - Communicates and escalates risks within the assigned studies and/or projects. - Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader. Qualifications - Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience. - Need to have Oncology TA experience. - Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology. - Good understanding of the clinical drug development process. - Strong communication skills and coordination skills. - Current knowledge of technical and regulatory requirements relevant for the role. - Ability to proactively manage concurrent activities within a project. - Proficient ability to influence relevant stakeholders on programming-related items. Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Role Description ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of our clients. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. - Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings; - Produce data listings, summary tables, and graphics for interim and final analyses; - Integrate data across studies within a project. Test, document, review, and validate all programs according to department guidelines; - Coordinate data transfer and/or programming standards with CROs and vendors. Validate analysis datasets and TFLs from vendors; - Collaborate with other Biometrics functions for all activities related to the analysis of clinical trial data; - Responsible for the execution of ad-hoc requests, manuscripts, posters, and presentations. Qualifications - Minimum of 10 years of SAS programming in the pharmaceutical or biotechnology industry with a BA/BS in computer science, statistics, math, or MA/MS with 8 years of experience; - Expertise in SAS programming language, report generation, and standards for programming and validation; - Therapeutic area - Rare Disease; - Experience with CDISC data standards required; - Experience as a senior statistical programmer at a pharmaceutical or CRO working in an FDA-regulated environment; - Experience with Clinical Study Reports and NDA submission; - Ability to work on multiple tasks simultaneously and meet project deadlines; - Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment. Application Process Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. - Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. - Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built. - Close management and training are the core instruments to develop and maintain highly-qualified personnel. - The continuous training keeps the resources qualified in terms of competence and expertise. - ClinChoice is an equal opportunity employer, guided by diversity and inclusivity.

• Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards. • Support TLF (Tables, Listings, Figures) generation in R or SAS as needed. • Write efficient, reproducible, and well-structured R scripts for clinical data analysis and reporting. • Collaborate with statisticians, data managers, and clinical teams to understand programming requirements. • Perform QC checks, reconcile data issues, and ensure deliverables meet regulatory expectations (e.g., FDA, EMA). • Contribute to programming workflows, documentation, and version control best practices. • Support automation initiatives and R-based pipeline development. • Utilize SAS for legacy studies or where SAS support is required.

• lead cross-functional teams and oversee the execution of complex clinical trials • ensure successful delivery in accordance with contractual commitments, SOPs, ICH-GCP guidelines, and applicable regulatory requirements

Role Description ClinChoice is searching for a Clinical R Programmer/Principal Data Scientist Consultant to join one of our clients. We are seeking a Principal Data Scientist Consultant with strong experience in R and a solid background in clinical programming. The ideal candidate will have hands-on experience developing SDTM and ADaM datasets using R, along with working knowledge of SAS. This role requires someone who can support clinical trial deliverables, ensure regulatory compliance, and collaborate closely with biostatistics and clinical data teams. - Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards. - Support TLF (Tables, Listings, Figures) generation in R or SAS as needed. - Write efficient, reproducible, and well-structured R scripts for clinical data analysis and reporting. - Collaborate with statisticians, data managers, and clinical teams to understand programming requirements. - Perform QC checks, reconcile data issues, and ensure deliverables meet regulatory expectations (e.g., FDA, EMA). - Contribute to programming workflows, documentation, and version control best practices. - Support automation initiatives and R-based pipeline development. - Utilize SAS for legacy studies or where SAS support is required. Qualifications - Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. - 4–6+ years of experience in clinical programming, with a strong focus on R. - Proven experience in creating SDTM and ADaM datasets using R. - Working knowledge of SAS programming. - Solid understanding of CDISC standards (SDTM, ADaM). - Experience with clinical trial data, regulatory submissions, and QC processes. - Strong analytical, problem-solving, and documentation skills. Requirements - Experience with R packages such as tidyverse, haven, pharmaverse (e.g., admiral, tidyCDISC), or other clinical programming toolkits. - Understanding of R Markdown, Shiny apps, or reproducible reporting tools. - Exposure to GxP validation, version control (Git), and automated workflows. - Experience working in a CRO or pharmaceutical environment. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Role Description - Manages Biometrics project teams from study start-up through study closeout; departments include Data Management, Biostatistics, Statistical Programming, and Medical Writing. - Manages multiple projects ranging in size and complexity from single service studies to large full scope biometrics projects, global projects and/or programs, with minimal oversight from supervisor. - Serves as the primary liaison between clients, vendors, and project teams. - Promotes team communication and cross functional collaboration in order to promote team spirit. - Establishes and maintains relationship between client, vendors and project team, to encourage repeat and/or new business. - Coordinates and leads team meetings. - Creates and distributes agendas and minutes. - Generates and maintains timelines, milestones, and action items. - Manages project financials; estimates monthly accruals and initiates timely invoice generation. - Identifies change orders items. - Oversees issues and facilitates issues resolution, and escalates, when needed. - Identify risks, mitigation, maintenance and resolution. - Ensures training required internally and by sponsor is completed. - Supports contract team with contracts (SOW, WO, COs, etc.) by developing the budgets and scope of work. - Provides performance feedback for project team and managers. - Supports business development activities (RFPs and RFIs) and governance activities, when required. - Performs other tasks as assigned by Sr. PM staff. Qualifications - Requires a bachelor’s degree or higher in life sciences. MBA or PMP is preferred. - Three plus years of experience in Pharma/CRO industry with 3+ Years’ experience in Project Management. - Possesses solid knowledge of Biometrics services and inter-dependencies. - Knowledge of FDA regulations, drug development and PM processes. - Good understanding of ICH/GCP guidelines. - Strong communication skills, both oral and written. - Strong team player and interpersonal skills and customer focused. - Proficiency in Microsoft Word, Excel, Power Point, Outlook and MS Project. Company Description ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Role Description ClinChoice is searching for a Principal Clinical Data Scientist Consultant – R Programmer to join one of our clients. We are seeking a Principal Clinical Data Scientist to join our Scientific Computing Technology group, which builds the open-source tools, R packages, SAS macros, and computing systems that power clinical programming, data management, and biostatistics across the organization. Reporting to the Director of Statistical Programming, this role blends hands-on clinical deliverables with contributions to the open-source and internal tooling that supports the wider clinical technical community. The ideal candidate has strong R skills, deep clinical programming experience, working Python familiarity, and an interest in modern, reproducible workflows. This position is open to remote candidates. Key Responsibilities - Develop, validate, and maintain SDTM and ADaM datasets in R — using admiral and the broader pharmaverse — following CDISC standards. - Generate Tables, Listings, and Figures (TLFs) in R or SAS as required by study needs. - Perform Pinnacle21 validation, resolve findings, and refine specifications to ensure CDISC compliance and submission readiness. - Write efficient, reproducible, well-structured R code for clinical data analysis and reporting. - Contribute to open-source and internal tooling — including R Shiny / teal modules, R packages, SAS macros, and Python utilities — used by clinical programming, data management, and biostatistics teams. - Partner with statisticians, data managers, and clinical teams to translate programming requirements into reliable deliverables. - Perform QC, reconcile data issues, and ensure outputs meet regulatory expectations (e.g., FDA, EMA). - Support automation, pipeline development, and version-controlled workflows. - Use SAS for legacy studies or where SAS support is needed. Qualifications - Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field. - 5+ years in clinical programming, with a strong focus on R. - Proven experience producing SDTM and ADaM datasets in R, including hands-on use of admiral. - Experience with Pinnacle21 validation and remediation. - Working knowledge of SAS programming. - Working knowledge of Python for analytics, scripting, or tooling. - Solid understanding of CDISC standards (SDTM, ADaM) and metadata-driven programming. - Experience with clinical trial data, regulatory submissions, and QC processes. - Strong analytical, problem-solving, and documentation skills. Preferred Qualifications - Broader pharmaverse experience (e.g., tidyCDISC, rtables) and tidyverse fluency. - Experience building or contributing to R Shiny apps, teal modules, or R packages used by other teams. - Exposure to AI/ML tooling in a clinical or programming context. - Real-World Evidence (RWE) experience — e.g., mapping Flatiron or claims/EHR data into CDISC-aligned structures. - R Markdown, Quarto, or other reproducible reporting workflows. - GxP validation, Git-based version control, and CI/CD or automated workflows. - CRO or pharmaceutical industry experience. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.