Job Description
Job Description
Principal Biostatistician
Position Overview
We are seeking an experienced Principal Biostatistician to provide statistical consultation for clinical development programs and to support clients in the auto-immune disease area.
The successful candidate will play a key role in study design, statistical analysis, regulatory interactions, and cross-functional collaboration throughout the clinical development lifecycle.
This position requires strong scientific judgment, excellent communication skills, and the ability to work effectively in a fast-paced biotech environment.
Key Responsibilities
- Statistical Leadership
- Lead statistical strategy for clinical development programs from Phase I through Phase III
- Provide hands-on support to delivery to clinical study protocols, statistical analysis plans (SAPs), specs to TFL outputs, SDTM/ADAM specs, and clinical study reports (CSRs)
- Study Design & Analysis
- Design clinical trials including sample size calculations, randomization schemes, and interim analysis planning
- Perform or oversee statistical analyses using SAS or R
- Interpret statistical results and communicate findings to cross-functional teams
- Regulatory & Documentation
- Ensure statistical deliverables meet FDA requirements
- Contribute to regulatory submissions including IND, NDA, and BLA
- Support interactions with regulatory agencies such as the FDA and EMA
- Cross-Functional Collaboration
- Collaborate with clinical development, statistical programming, data management, and regulatory teams
- Provide statistical guidance to internal teams and external biotech partners
Qualifications
- Education
- PhD or MS in Statistics, Biostatistics, or related quantitative discipline
- Experience
- PhD with 5+ years of industry experience, or MS with 7+ years
- Experience supporting clinical trials in the pharmaceutical or biotech industry
- Experience with regulatory submissions are preferred, but not must
- Technical Skills
- Proficiency in SAS and/or R
- Experience with clinical trial design and statistical methodology
- Familiarity with CDISC standards (ADaM/SDTM) is a must
- Soft Skills
- Strong communication and presentation skills
- Ability to work independently and manage multiple projects
- Experience working in a biotech or consulting environment is highly preferred
- What We Offer
- Opportunity to work with innovative biotech companies globally
- Exposure to diverse therapeutic areas and development programs
- Flexible remote work environment
- Collaborative and entrepreneurial culture
Job Type: Contract
Pay: $250,000.00 - $300,000.00 per year
- Schedule:
- Monday to Friday
Work Location: Remote
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