Associate Biostatistics Director – Permanent Home‑Based

About the role

The Associate Biostatistics Director will lead the full scope of biostatistical activities for a therapeutic‑area program, defining statistical strategy and ensuring rigorous methodology for study design, data analysis, and regulatory submissions. This permanent, home‑based position works closely with cross‑functional teams and regulatory authorities.

Key responsibilities

• Define and implement statistical strategies for clinical trial design, analysis, and regulatory submissions.
• Lead statistical discussions during protocol development and serve on Study Executive and Clinical Development Teams.
• Provide statistical thought partnership for innovative designs, Go/No‑Go criteria, and probability of technical success calculations.
• Oversee project‑wide planning, execution, and timely delivery of interim, final, and integrated analyses.
• Represent Biostatistics in interactions with FDA, EMA, PMDA and other authorities.
• Interpret analysis results and ensure accurate reporting in study reports and regulatory documents.
• Prepare abstracts, posters, oral presentations, and written reports for internal and external audiences.

Required profile

• PhD or MS in Biostatistics, Statistics or a related field.
• Minimum 8 years of experience in clinical trial statistics, preferably in pharma or CRO environments.
• Proven track record in strategic study design, adaptive designs, sample‑size calculations and interim analysis planning.
• Familiarity with regulatory guidance (FDA, EMA, PMDA) on statistical methodologies.
• Strong communication skills and ability to collaborate with clinical and regulatory teams.

Required skills

• SAS
• R
• Bayesian methods
• Predictive modeling
• Simulation techniques
• Adaptive design methodology
• Sample‑size calculation
• Interim analysis planning