- Build and lead the Biostatistics and Data Management functions within the organization, managing a team of statisticians, programmers, and data managers to ensure the timely and accurate delivery of statistical outputs for clinical studies.
- Develop statistical analysis plans and oversee the implementation of statistical methodologies for clinical studies, ensuring their compliance with regulatory guidelines and data management standards for regulatory inspections and/or submissions.
- Provide strategic input to study design, protocol development, and clinical development plans to ensure optimal study designs and efficient use of resources.
- Collaborate with cross-functional teams including clinical development, clinical operations, regulatory affairs, pharmacovigilance, and medical affairs to ensure the successful execution of clinical trials.
- Ensure that all statistical analyses are of high quality and are appropriately documented, and that the conclusions drawn from the analyses are supported by the data.
- Provide statistical support for regulatory submissions, including authoring and reviewing statistical sections of regulatory documents.
- Ensure compliance with applicable regulatory guidelines, industry standards, and company policies.
- Manage departmental resources, including budget, personnel, vendor oversight, and technology infrastructure, to ensure the delivery of high-quality statistical input.
- Develop and maintain relationships with key external stakeholders, including regulatory agencies, academic institutions, contract research organizations, vendors and other industry organizations.