Job Description
Associate Director, Biostatistics
Position Overview
We are seeking an experienced Associate Director, Biostatistics 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