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:
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.
