Full-Time Associate Director, Biostatistics

Associate Director, Biostatistics

Position Summary: The Associate Director of Biostatistics acts as a statistical lead for multiple clinical studies and/or a clinical development program. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Participates in regulatory interactions and submissions to the FDA and other regulatory agencies; Contributes to the biometrics effort across the different programs to identify, develop and implement departmental standards, applications, processes, and training.

Key Responsibilities Include:

• Contribute to study level tasks from statistics perspective, including study design and sample size determination.
• Author/review statistics section in the protocol, SAP and DMC charter.
• Create/review study randomization files.
• Develop TFL shell and specification.
• Review CRFs and other study documentations.
• Active participation in study related meetings.
• Contribute strategically to supporting projects and regulatory interactions from the statistics perspective.
• Work collaboratively with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
• Oversee statistical work by CRO and ensure quality deliverables.
• Translate statistical thinking into a strategic input to advance the clinical program.
• Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches.
• Ensure statistical integrity of deliverables; provide scientifically sound methodology input.
• Author/review regulatory documents or scientific publications.
• Contribute to project budget/resource planning, re-forecasting, and program milestones.

Education, Registration & Certification: PhD in Statistics, Biostatistics or Mathematics with a minimum of 5 years (minimum 8 years for master’s degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry.

Experience:

• Adept at outsourcing and managing biostatistical services provided by CRO’s and contractors.
• Experienced as product lead statistician and contribute to strategy discussion in cross-functional settings.
• Experienced in managing multiple products and studies and being able to prioritize.
• Experienced in study level work including authoring SAP and TFL specification.
• Develop SAS programs as necessary to perform planned or ad hoc analyses.
• Some knowledge about ICH guideline, FDA/EMA/other regulatory authority guidance.
• Solid understanding of mathematical and statistical principles.
• Experience in statistical methods (longitudinal data analyses, Bayesian method, adaptive design, Simulations).
• Excellent communication and interpersonal skills, with the ability to translate statistical concepts to program strategies.
• Detailed-oriented with organization, problem-solving and prioritization skills.
• Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies.
• Positive and collaborative attitude.

Physical Demands and Work Environment: Largely sedentary role, some filing required.

Travel Requirements: Up to 15% travel expected.

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