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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 Ph.D. or M.S. in Biostatistics, Statistics, or a related quantitative field. For Senior Director: Minimum 12+ years of experience in biostatistics within the pharmaceutical/biotech industry. For Executive Director: Minimum 15+ years of experience with increasing leadership responsibilities. Extensive experience in statistical design and analysis of Phase I-III clinical trials. Proven track record of regulatory interactions and successful NDA/BLA/MAA submissions. Strong leadership and people management experience, including mentoring and developing teams. Proficiency in SAS, R, and other statistical programming languages. Excellent communication skills, with the ability to translate complex statistical concepts for cross-functional teams and regulatory agencies. Seniority level

Executive Employment type

Full-time Job function

Management, Analyst, and Science Industries

Pharmaceutical Manufacturing and Biotechnology Research

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