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Associate Director/Director, Biostatistics

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The Associate Director/Director of Biostatistics will provide statistical leadership, oversight, and statistical expertise to support the clinical development of multiple clinical trials. This is a remote role that may require ~10% travel.

Essential Responsibilities

• Provide scientifically sound statistical input into clinical development plans, protocol development and sample size/power calculations
• Lead the development of statistical analysis plans for individual clinical trials and integrated summary of efficacy/safety of multiple trials; help the team to interpret the study results and contribute to Clinical Study Report(s)
• Review and provide feedback to Case Report Forms, CRF completion guidelines, data transfer agreement and data review plans
• Oversee and manage CRO’s activities to ensure high-quality and on-time deliverables, and that statistical analyses and reporting meet internal standards and regulatory requirements
• Review study randomization to ensure that randomization plans are aligned with protocol specifications
• Lead the development of Tables/Listings/Figures; review and/or validate SDTM/ADaM specifications/data sets and TLFs
• Apply innovative statistical methodologies to trial designs and analyses (e.g., modeling and simulation, Bayesian statistics, etc.)
• Contribute to the creation and review of study-related documents, such as protocol, DMC charter, and other key study documents, ensuring alignment with statistical methodologies and regulatory standards
• Participate in meetings with regulatory agencies; contribute to the pre-meeting packages and prepare responses to agency’s requests/questions
• Perform ad-hoc analyses and exploratory biomarker analyses
• Collaborate closely with statistical programming, clinical science, data management, clinical operation, pharmacovigilance, and regulatory to ensure operational excellence

Required/Preferred Education, Skills, and Qualifications

• D. or a Master’s degree in statistics or related field with a minimum of 6 years (Ph.D.) or 8 years (Master) of relevant experience in biotechnology or pharmaceutical industry
• Solid knowledge of statistical methodologies and experimental designs
• Advanced skills in statistical software for sample size calculation; advanced skills in SAS and R programming
• Capable of leading statistical activities from first-in-human trials to later phases of clinical development
• Extensive knowledge of CDISC standard
• Oversight experience managing CROs
• Oncology experience is required
• Experience with NDA/BLA submission and/or experience with ISS/ISE is a plus
• Thorough knowledge of drug development process and regulatory guidance
• Solid understanding of ICH/GCP guidelines
• Ability to prioritize and manage multiple tasks simultaneously
• Excellent communication/interaction skills and ability to collaborate with a global multicultural team

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