Senior Biostatistician II

Vertex Pharmaceuticals•Boston, MA

3d•Hybrid

About The Position

The Senior Biostatistician II will perform scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with guidance and mentoring on new and complex issues. The incumbent will complete assigned work in a resourceful manner and create alternative approaches to achieve desired results. The incumbent will develop a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Requirements

Competence with SAS and R statistical software
Demonstrated understanding of 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
Ph. D. or master's degree in Statistics or Biostatistics.
Typically requires 3 years of experience for those with a master's degree or the equivalent combination of education and experience.

Responsibilities

Within assigned area, designs, develops and executes the technical/statistical infrastructure for the conduct and evaluation of clinical trials, observational studies, or real world data (RWD) investigations, including related areas/activities.
Participates in regular Study Execution Team (SET) team meetings as the functional representative.
Works under supervision to author study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells, and presentation to Statistical Review Forum (SRF).
Plans and conducts Cross-functional Data Review (xFDR) , Key Results 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 good quality.
Provides input into programming specifications and review.
Develops statistical section of protocols, including sample size estimates and randomization plan.
Contributes to clinical study reports (CSRs) and related processes.
May author or co-author methodological or study-related publications and posters.
Implements design and analysis methods at the study level and participates in SRF discussions of studies assigned to others.
Contributes to departmental working group efforts on various technical and operational issues.
Seeks guidance and mentoring on new and complex issues
Completes assigned work in a resourceful manner and creates alternative approaches to achieve desired results if needed.
Develops a basic knowledge of related disciplines with a drug developer mindset.