Biostatistics Director
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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**
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