Associate Director, Biostatistics

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Requirements:

• PhD in Statistics, Biostatistics, or Mathematics with a minimum of 5 years (8 years for master’s degree) of post-graduate experience in clinical trials.
• Experience in managing biostatistical services from CROs.
• Acted as product lead statistician in cross-functional discussions.
• Adept in study-level work including authoring SAPs.
• Knowledge of ICH guidelines and FDA/EMA guidance.
• Solid understanding of statistical methods preferred (longitudinal analysis, Bayesian methods, adaptive design, simulations).
• Communication skills to translate statistical concepts into strategies.
• Proficiency in SAS and R, familiarity with CDISC including SDTM and ADaM.

Responsibilities:

• Act as statistical lead for multiple clinical studies and clinical development programs.
• Provide leadership in designing studies and selecting statistical methods.
• Participate in regulatory interactions and submissions.
• Contribute to biometrics standards and training.
• Author/review statistical sections in protocol, SAP, and DMC charter.
• Review study documentations and participate in study meetings.
• Oversee statistical work by CROs, ensuring quality deliverables.
• Conduct independent analyses and propose novel methodologies.
• Ensure statistical integrity of deliverables and provide methodological input.
• Author/review regulatory documents or scientific publications.