Biostatistics Associate Director (HYBRID)

Vertex Inc.•Boston, MA

63d•$174,800 - $262,200•Hybrid

About The Position

The Biostatistics 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 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. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Requirements

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

Nice To Haves

Some prior staff management experience is typical

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.
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.