Biostatistics Director
vor 3 Wochen
Biostatistics Director
Location: Basel
Start: ASAP
Duration: 12 months
Workload: Full-time
Our client, a renowned clinical-stage biotech company based in Basel, is seeking an experienced Biostatistics Director to join their dynamic team. This is an exceptional opportunity for a seasoned professional to play a pivotal role in the strategic, methodological, and operational clinical development activities within multiple therapeutic areas.
Your Tasks:
Shape clinical development plans, regulatory strategies, and life cycle planning to ensure optimal design and execution of clinical programs.Provide expert statistical advice and strategic inputs on drug development to senior management and internal staff.Develop study protocols, clinical study reports, and generate complex randomization schedules. Ensure accurate sample size estimates and power calculations.Oversee and approve primary and secondary manuscripts of clinical trial results.Develop and execute statistical analysis plans, perform advanced statistical analyses, and oversee the creation of tables, listings, and figures for study reports and manuscripts.Act as the statistical liaison to FDA and other regulatory agencies, ensuring documents are accurate and statistically sound.Communicate effectively with team members, senior management, external experts, and regulatory authorities.Provide coaching and feedback to support professional development and business goals.Your Profile:
PhD in Biostatistics, Statistics, or related disciplines.At least 10 years of pharmaceutical experience, including direct supervisory and management experience.Strong knowledge of statistical methodology in design and analysis, with experience in adaptive designs, Bayesian methods, and advanced statistical modeling.Extensive knowledge of FDA/ICH guidelines, CDISC standards, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines.Proficient in major statistical software programs such as SAS and/or R.Please apply directly online with your CV.
**Please only apply if you are eligible to work in Switzerland and the EU**
headcount AG
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