Job Description

Job Description

Principal Biostatistician – Pharma / Biotech

Raleigh–Durham, NC | Full-Time, Permanent | Pharmaceutical Industry

About the Company:

Our client is a leading pharmaceutical company with a strong global footprint in innovative drug development. From discovery through commercialization, they are committed to delivering life-changing therapies to patients worldwide. Their U.S. operations in the Research Triangle Park area are at the forefront of data-driven decision making, clinical development, and regulatory science.

The Role:

As a Principal Biostatistician , you will be a senior member of the Biostatistics team, providing strategic statistical leadership across multiple clinical trials and development programs. You will collaborate cross-functionally with Clinical, Regulatory, Data Management, and Programming teams to ensure the highest scientific and regulatory standards are met.

Key Responsibilities:

• Lead statistical strategy and design for clinical studies across all phases (I–IV).
• Provide expert input into study protocols, statistical analysis plans, and clinical study reports.
• Oversee and review statistical deliverables, ensuring accuracy, compliance, and consistency with ICH guidelines.
• Mentor and provide technical oversight to junior biostatisticians.
• Serve as the primary statistical representative in regulatory meetings and submissions (FDA, EMA, etc.).
• Partner with cross-functional teams to drive evidence-based decision making.

Qualifications:

• MSc or PhD in Biostatistics, Statistics, or a related field.
• 8+ years of relevant experience in pharmaceutical or biotech clinical development.
• Deep understanding of statistical methodologies for clinical trials, including survival analysis, mixed models, and multiplicity adjustments.
• Hands-on experience with SAS (required) and R (preferred).
• Proven track record of successful regulatory submissions.
• Strong communication skills, with the ability to convey complex statistical concepts to non-statistical audiences.

What’s on Offer:

• Competitive base salary plus annual bonus and stock options .
• Comprehensive health, dental, and vision coverage.
• 401(k) with company match.
• Generous PTO and flexible working arrangements.
• The opportunity to work on high-impact programs within one of the U.S.’s most vibrant biotech hubs.

Location:

This role is based in the Raleigh–Durham Research Triangle Park area — home to a thriving life sciences community, top universities, and an exceptional quality of life.

How to Apply

If you are ready to take the lead in shaping the statistical backbone of ground-breaking clinical programs, please apply directly here or contact me on the below details for more information:

joel.isaac@vividresourcing.com

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