Principal Scientist, Biostatistics, Late-Stage Clinical Development

About the role

The Principal Scientist in Biostatistics will lead statistical strategy for late‑stage clinical development of drugs and vaccines. Working within BARDS, you will partner with clinical, regulatory, data management and programming teams to ensure robust trial design and analysis.

Key responsibilities

• Serve as statistical lead on cross‑functional project teams, guiding design, analysis and interpretation of late‑stage clinical trials.
• Develop protocols, data analysis plans and determine appropriate statistical methodologies.
• Collaborate with Clinical, Regulatory, Data Management and CROs to coordinate statistical activities.
• Lead or mentor a team of statisticians and programming staff, ensuring compliance with SOPs and regulatory requirements.
• Represent biostatistics in regulatory interactions and prepare statistical review aids for submission.

Required profile

• PhD in statistics/biostatistics (or equivalent) with at least 6 years of relevant experience, or a Master’s with at least 9 years.
• Strong knowledge of experimental design, statistical analysis methods and worldwide regulatory requirements for phases II‑V trials.
• Excellent oral and written communication skills and ability to work effectively in multidisciplinary teams.

Required skills

• SAS
• R
• Statistical analysis and modeling
• Clinical trial design and data management
• Statistical programming

What we offer

• Salary range $190,800 – $300,300 per year.
• Eligibility for annual bonus and long‑term incentives.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays and vacation.