Associate Biostatistics Director - FSP (Permanent Home-based)

Lead full scope of Biostatistics conduct for a responsible program within a therapeutic area, defining statistical strategy and ensuring appropriate methodologies applied to study design and data analysis for clinical trials and regulatory submissions.

Requirements

• PhD or MS in Biostatistics, Statistics or related field
• Minimum of 8 years of experience in clinical trial statistics, preferably within a pharmaceutical or CRO setting
• Advanced proficiency in SAS / R for data analysis and statistical programming
• Experience with Bayesian methods, predictive modeling, and simulation techniques
• Proven track record in strategic study design, including adaptive designs, sample size calculations, and interim analysis planning
• Familiarity with regulatory guidance on statistical methodologies (e.g., FDA, EMA, PMDA)
• Leading roles in regulatory submissions
• Experience in interactions with major regulatory authorities preferred

Benefits

• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Relocation Assistance