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Associate Director, Biostatistics

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Tuesday, January 16, 2024

Job Description

General Summary:

As a Biostatistics Associate Director at Vertex, you will be at the forefront of cutting-edge medical research, analyzing complex data to unravel crucial insights that may leads to medical breakthroughs.

You will collaborate with interdisciplinary teams, applying novel statistical methodologies to solve real-world challenges, ultimately contributing to the development of life-saving treatment and improving global well-being.

The Associate Director 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 should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Key Duties and Responsibilities:

  • 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.
  • 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.
  • 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:

  • 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

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.

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.