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Senior Biostatistics Lead
2 weeks ago
Role Overview
Job DescriptionWe are seeking a highly skilled Principal Biostatistician to lead components of statistical contribution to a clinical development program. The ideal candidate will implement the statistical strategies for clinical trials and regulatory submissions within the program, ensuring timely completion and quality of deliverables.
Main Responsibilities:
- Develop and execute statistical strategies for study design and data analysis in clinical trials and regulatory submissions.
- Collaborate with cross-functional teams to develop study protocols, data collection plans, and statistical analysis plans.
- Author initial statistical analysis plans for clinical trials and regulatory submissions, ensuring accuracy and timeliness.
- Support interactions with regulatory authorities (e.g., FDA, EMA, PMDA) to ensure compliance and successful submissions.
- Analyze and interpret results from clinical trials and regulatory submissions, providing accurate reporting and recommendations.
- Manage outsourcing operations or work with internal statistical programmers to ensure quality and timeliness of deliverables.
- Be accountable for TFL/CDISC package preparation for study report and regulatory submission.
- Contribute to innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
