Principal Biostatistician

Vertex Inc.•Boston, MA

9d•$152,000 - $228,000•Hybrid

About The Position

The Principal Biostatistician will perform advanced scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with some 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 should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Requirements

Ph. D. or master's degree in Statistics or Biostatistics.
Typically requires 3 years of experience with a Ph.D. or 6 years of experience with a master's degree, or the equivalent combination of education and experience.
In-depth experience with SAS and R statistical software
Demonstrated 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

Nice To Haves

Possesses an advanced understanding of modern drug discovery and development processes.

Responsibilities

Conducts advanced scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations, including the design, development and execution of the technical/statistical infrastructure.
Represents Biostatistics as a member of clinical trial teams, providing input and 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 good quality.
Contributes to external interactions with regulators, payers, review boards, etc.
Develops statistical section of protocols, including sample size estimates and randomization plans.
Contributes to clinical study reports (CSRs) and related processes.
Authors or co-authors methodological or study-related publications and posters.
Provides input into programming specifications and review.
Implements design and analysis methods at the study 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.
Undertakes new and complex issues with minimal guidance.
Completes assigned work in a resourceful, self-sufficient manner and creates alternative approaches to achieve desired results if needed.
Develops breadth of knowledge across related disciplines with a drug developer mindset.