Associate Director Biostatistics

What You’ll Do: Act as asset‑level statistical lead, owning studies from design through analysis and submission Define and execute statistical strategy for registration‑directed trials Author and oversee SAPs, analysis plans, and reporting deliverables Provide input into study design, endpoints, and analysis approach Guide simulation work and innovative design considerations where appropriate Partner closely with Clinical Development, Regulatory, Medical, and Data Science teams Represent Biostatistics in cross‑functional governance and decision forums Ensure high‑quality, timely delivery through internal teams and external vendors What They’re Looking ForPhD in Biostatistics, Statistics, or a related discipline ~8–10+ years of industry experience in clinical development Experience leading Phase I–IV clinical trials Strong understanding of statistical methodology and its clinical application Confidence handling missing data strategies and regulatory‑grade analyses Ability to communicate complex statistical concepts to non‑statisticians Experience with SAS; R exposure for simulation work is beneficial Why It’s InterestingTrue asset ownership and accountability Statisticians positioned as decision‑makers, not support resources High visibility within a growing US development organisation Opportunity to influence study design and evidence strategy Competitive compensation and long‑term growth potential