Principal Biostatistician

General Summary

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 complete 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.

• 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.
• Possesses an advanced understanding of modern drug discovery and development processes.
• Represents Biostatistics as a member of clinical trial teams, providing input and technical guidance to elicit meaningful and/or productive outcomes.
• With minimal guidance, 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. Also 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.

• 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.

• 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.
• Ph.D. or master's degree in Statistics or Biostatistics.

$174,800 - $262,200

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.

At Vertex, our Total Rewards offerings also include inclusive market‑leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week‑long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Hybrid‑Eligible or On‑Site Eligible

• Hybrid: work remotely up to two days per week; or select
• On‑Site:…