BiostatisticsDirector-IndicationLead

## Accountabilities Serve as the indication lead biostatistician, owning and driving all statistical activities across a major clinical indication spanning multiple assets. Lead the development and execution of the quantitative data strategy, ensuring alignment with overall clinical development and regulatory objectives. Oversee and deliver all statistical outputs across the indication, including contributions to global health authority submissions (e.g., BLA, NDA, MAA). Drive the design and application of innovative statistical methodologies and complex clinical trial designs across all development stages. Collaborate closely with cross-functional stakeholders, including clinical, regulatory, and program teams, to ensure high-quality and timely delivery of statistical deliverables. Guide and mentor a team of statisticians supporting multiple assets within the indication, fostering technical excellence and consistency. Ensure all statistical activities comply with internal standards, regulatory requirements, and industry best practices. Contribute to strategic decision-making by translating complex statistical insights into clear, actionable recommendations. Requirements: Master’s degree or PhD in Statistics, Biostatistics, or a related field. Minimum of 7+ years of experience in the pharmaceutical or biotech industry. Proven track record of leading statistical strategy for clinical programs, including regulatory submissions (BLA/NDA/MAA) and health authority interactions. Strong expertise in clinical trial design and advanced biostatistical methodologies, including innovative and complex approaches. Proficiency in statistical programming languages such as SAS and/or R. Strong ability to collaborate effectively with cross-functional teams and senior stakeholders in a matrixed environment. Excellent written and verbal communication skills, with the ability to clearly explain complex statistical concepts in English. Demonstrated leadership ability, including mentoring