Biostatistics Director

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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