Biostatistics Associate Director

Job Description

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 completed 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.

As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

• 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.
• Manages one or more team members, including their performance and development.
• 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) 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.
• Contributes to external interactions with regulators, payers, review boards, etc.
• 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.

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

• Typically requires 7 years of experience with a Ph.D. or 10 years of experience with a master’s degree, or the equivalent combination of education and experience
• Ph.
  
  D. or master’s degree in Statistics or Biostatistics.

$236,000 - $354,000

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

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