Senior Director, Biostatistics

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Responsibilities:  The Translational Medicine Statistics (TMS) group is a unit of the Early Development Statistics (EDS) department within the Biostatistics and Research Decision Sciences (BARDS) organization of Our Company's Research Laboratories. The primary responsibility of TMS is to provide statistical support for the pharmacology components of all clinical trials in our Company's Research Laboratories clinical development pipeline. Also in scope prior to an asset’s potential advancement to late stage clinical development are proof of biology/concept clinical trials, experimental/discovery medicine trials involving novel pharmacodynamic endpoints/platforms, and early phase vaccine trials.

Reporting to the Executive Director and Head of TMS (in EDS/BARDS), the incumbent will manage a group of at least 5 statisticians. This requires a broad, comprehensive knowledge of statistics and its applications in clinical drug development.

Primary Activities:

• Report to the Executive Director and Head of TMS (in EDS/BARDS).

• Serve as a member of the EDS Leadership Team.

• Build/sustain a high performing statistics group to support translational medicine projects as a manager of at least 5 statisticians.

• Serve as a reviewer for the cross-functional translational medicine document review committee.

• Support due diligence in-licensing projects in the translational medicine space.

• Represent TMS on statistical matters involving regulatory interactions for assigned translational medicine projects.

• Support the development and deployment of state-of-the-art statistical methods for all in-scope projects.

• Support outsourcing efforts involving translational medicine activities.

Education and Minimum Requirements:

• PhD in statistics/epidemiology/data science with at least 10 years experience (or MS in statistics/epidemiology/data science with at least 12 years experience) in statistical design/analysis/reporting of clinical trials.

Required Skills and Experience: Excellent oral and written communication skills. Experience in collaborating with translational medicine and other clinical development professionals. Record of working effectively in a fast-paced cross-functional team environment. Working knowledge of requirements of clinical pharmacology components of regulatory filings.

Preferred Skills and Experience:  Solid project management skills and the ability to partner with senior-level leaders across multiple departments. Understanding of the discovery, early-phase and late-phase clinical and translational drug development processes applicable to a broad portfolio of drug and vaccine candidates.

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