Responsibilities:
Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture. Recruit, mentor, and inspire the team to ensure organizational capability scales with the company's clinical portfolio.
Serve as a strategic advisor to executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making. Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection to optimize probability of technical and regulatory success.
Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings. Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning.
Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies. Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation.
Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making. Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials.
Late stage development experience is strongly preferred. Represent the company in regulatory meetings as needed and ensure alignment with global regulatory standards and evolving guidance.
Oversee CROs, data vendors, and technology platforms to ensure high-quality deliverables, on-time execution, and compliance with regulatory and industry standards. Champion modern data management and statistical computing practices, ensuring infrastructure supports scale, audit readiness, and efficiency.
Stay abreast of emerging statistical methodologies, regulatory trends, and industry best practices to ensure the organization remains at the forefront of scientific and statistical innovation.
Qualifications:
• Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture. • Recruit, mentor, and inspire the team to ensure organizational capability scales with the company's clinical portfolio. • Serve as a strategic advisor to executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making. • Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection to optimize probability of technical and regulatory success. • Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings. • Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning. • Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies. • Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation. • Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making. • Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials. • Late stage development experience is strongly preferred. • Represent the company in regulatory meetings as needed and ensure alignment with global regulatory standards and evolving guidance. • Oversee CROs, data vendors, and technology platforms to ensure high-quality deliverables, on-time execution, and compliance with regulatory and industry standards. • Champion modern data management and statistical computing practices, ensuring infrastructure supports scale, audit readiness, and efficiency. • Stay abreast of emerging statistical methodologies, regulatory trends, and industry best practices to ensure the organization remains at the forefront of scientific and statistical innovation.