What are the responsibilities and job description for the Senior Director - Executive Director Biostatistics position at The Lotus Group LLC?
The Lotus Group has partnered with a leading biopharmaceutical company dedicated to advancing innovative therapies that improve patient outcomes. This client has been growing significantly through a very dormant time for the industry.
Position Summary
We are seeking a highly experienced and strategic Senior Director / Executive Director of Biostatistics to lead biostatistics and provide statistical leadership across clinical development programs. This role will be instrumental in shaping statistical strategy, ensuring regulatory compliance, and guiding data-driven decision-making for pivotal trials and regulatory submissions.
Key Responsibilities
- Provide statistical leadership and strategic oversight for clinical development programs, from early-phase studies through regulatory approval.
- Serve as the primary biostatistics representative in cross-functional teams, including Clinical Development, Regulatory Affairs, Medical Affairs, and Data Science.
- Develop and implement statistical methodologies for study design, protocol development, data analysis, and interpretation of results.
- Lead statistical aspects of regulatory interactions, including FDA / EMA meetings, responses to health authorities, and submission activities (e.g., NDA / BLA / MAA).
- Oversee the development and review of statistical analysis plans (SAPs), ensuring robust statistical approaches and regulatory compliance.
- Manage and mentor a team of biostatisticians and statistical programmers, fostering professional development and scientific excellence.
- Partner with external stakeholders, including CROs, academic collaborators, and regulatory agencies, to support clinical trial execution and data analysis.
- Evaluate and implement innovative statistical methodologies, including Bayesian approaches, adaptive trial designs, and real-world evidence (RWE) strategies.
- Ensure adherence to ICH guidelines, GCP, and industry best practices in statistical analysis and reporting.
Qualifications
Seniority level
Executive
Employment type
Full-time
Job function
Management, Analyst, and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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