Biostatistics Associate Director; HYBRID

Key Responsibilities

• Conduct scientific and operational statistical work for multiple clinical trials, observational studies, and real‑world data investigations.
• Lead biostatistics projects or major project components, including work allocation and review.
• Present to the Peer Protocol Review Committee (PPRC) or other internal senior review boards as required.
• Represent Biostatistics on cross‑functional teams, providing input and technical guidance to drive productive outcomes.
• Author Statistical Analysis Plans (SAPs) and table/figure/Listing (TFL) shells.
• Develop Cross‑Functional Data Review (xFDR) plans, Key Reports Memos (KRMs), and Data Dissemination Plans (DDPs) to facilitate review and dissemination of key study data.
• Collaborate with statistical programming and other functions to ensure timely delivery of high‑quality TFLs.
• Contribute to clinical study reports (CSRs) and related processes, authoring or co‑authoring methodological or study‑related publications and posters.
• Provide input into programming specifications and review.
• Participate in external interactions with regulators, payers, and review boards.
• Determine and implement study or project‑level design and analysis methods, and contribute to Statistical Review Forum (SRF) discussions.
• Participate in departmental working group efforts on advanced technical and operational issues.

• Prior staff management experience, typically.
• In‑depth competence with SAS and R statistical software.
• Advanced understanding of statistical methods used in drug development.
• Strong critical‑thinking and logical problem‑solving skills.
• Excellent written and verbal communication abilities.
• Team‑oriented and collaborative with non‑statisticians.
• Experience with NDA/MAA and direct dealings with USA/European regulators.

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

Base salary range: $174,800 – $262,200. Eligible for annual bonus and equity awards. Overtime pay, where applicable, follows federal and state requirements.

Hybrid‑Eligible: work remotely up to two days per week or on‑site five days per week with ad‑hoc flexibility as per company policy.

Market‑leading benefits including medical, dental, vision, paid time off, educational assistance, commuting subsidy, 401(k), and other resources to support growth.

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.