Principal Biostatistician

Overview
Principal Biostatistician (Medical Affairs - CAN & Europe)
Responsibilities
Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the study to ensure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses.
Be accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc.; Statistical Analysis Plan (SAP); data surveillance; statistical analysis results for CSR and its appendices (TLGs and in-text tables).
Effectively utilize external groups, e.g., CROs or data monitoring committees (DMC).
Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan.
Perform and/or coordinate with the study programmer the production of statistical analyses; review and examine statistical data distributions/properties.
Oversee execution of the statistical analyses according to the SAP; prepare statistical methods and provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure statistical integrity of the content in accordance with internal standards and regulatory guidelines and SOPs.
Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.
Contribute to define and review the specific deliverables related to Transparency and Disclosure.
Plan and track study/project activities and timelines.
Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation.
Qualifications
PhD/MS in statistics or related discipline with at least 5 years of pharmaceutical experience.
Good knowledge of pharmaceutical clinical development, together with late phase and/or post-marketing activities.
Broad knowledge and good understanding of advanced statistical concepts and techniques.
Able to work in a departmental computing environment; able to perform advanced statistical analyses using SAS and possibly other languages (e.g., R).
Demonstrated strong interpersonal, communication, and writing skills.
Working experience in clinical development such as interaction with external stakeholders.
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Note: Summary clarifies role eligibility and does not modify documented responsibilities or qualifications. The Company is committed to compliance with applicable laws and regulations, including the EU Equality Directive and the Americans with Disabilities Act where applicable.
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