Biostatistics Associate Director; Hybrid

Role Summary

The Associate Director, Biostatistics will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with minimal guidance and mentoring on new and complex issues. The incumbent will complete work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The incumbent is capable of independent strategic and technical contributions. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

• 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.
• May include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
• Possesses an advanced and in-depth understanding of modern drug discovery and development processes.
• 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.

• Required:
  
  Ph.D. or master's degree in Statistics or Biostatistics. Typically requires 7 years of experience with a Ph.D.
• Preferred: NDA/MAA experience and direct dealings with USA/European regulators

• 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
• Excels in a team environment
• Collaborates well with non-statisticians
• NDA/MAA experience and direct dealings with USA/European regulators

• Ph.
  
  D. or master's degree in Statistics or Biostatistics.