Biostatistics Associate Director (HYBRID)

Key Duties And Responsibilities

• Counsels on and conducts all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations.
• Leads biostatistics projects or major components of a project including work allocation and review.
• Presents to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
• Represents Biostatistics as a member of cross-functional teams, providing input and specialized technical guidance to elicit meaningful and/or productive outcomes.
• Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells.
• Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results.
• Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality.
• Contributes to clinical study reports (CSRs) and related processes, authoring or co-authoring methodological or study-related publications and posters.
• Provides input into programming specifications and review.
• Collaborates with external interactions with regulators, payers, review boards, etc.
• Authors or co-authors methodological or study-related publications and posters.
• Determines and implements design and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
• Contributes to departmental working group efforts on various advanced technical and operational issues.
• Independently undertakes new and complex issues.
• Completes assigned work in a resourceful, self-sufficient manner, often conceptualizing alternative approaches to achieve desired results.
• Develops breadth of knowledge across related disciplines with a drug developer mindset.

Knowledge And Skills

• Some prior staff management experience is typical.
• In-depth competence with SAS and R statistical software.
• In-depth understanding of advanced statistical methods used in drug development.
• Ability to show critical thinking with logical problem-solving.
• Excellent written and verbal communication skills.
• Excellence in a team environment.
• Collaborates well with non-statisticians.
• NDA/MAA experience and direct dealings with USA/European regulators.

Education And Experience

Ph. D. in Statistics or Biostatistics. Typically requires 7 years of experience with a Ph.D. or the equivalent combination of education and experience.