Director, Biostatistics

Director, Biostatistics


Job Summary:
We are seeking an experienced Director of Biostatistics to provide scientific and technical leadership for our clinical development programs. In this role, you will lead all biostatistical activities and serve as a biostatistical expert across all assigned projects, ensuring the highest standards of scientific rigor and regulatory compliance.
Key Responsibilities:
• Provide statistical leadership and support across all clinical development functions and lead all assigned projects within the Biometrics department.
• Participate and interact with clinical and cross-functional teams in the development of protocols, study design, and endpoints discussions.
• Develop and review statistical sections of protocols, SAPs, study reports, and regulatory documents.
• Apply advanced statistical methodologies, such as survival analysis, Bayesian analysis, handling missing data and adaptive designs.
• Provide statistical support to Clinical Operations, Regulatory Affairs, Medical Affairs, Translational science, and RWE functions.
• Support regulatory submissions work and generation of ISS/Client.
• Ensure consistency within Biometrics functions, including Programming and Data Management, for all deliverables to enhance efficiency and quality.
• Represent Biostatistics in meetings with regulatory authorities.
• Develop and implement departmental SOPs for statistical activities in accordance with ICH, GCP, guidelines, and CDISC standards (SDTM/ADaM).
• Manage and oversee the work of CROs and other external vendors to ensure the quality and timeliness of deliverables.
Qualifications, Experience, & Competencies:
• A master's or PhD degree in biostatistics or a related field is required.
• At least 10 years of experience in the pharmaceutical, biotechnology, or contract research organization (CRO) industry is essential.
• Proficiency in SAS and/or R. Familiarity with CDISC standards (SDTM, ADaM) is essential.
Page 2 of 2
• In-depth experience and expertise in applying biostatistical methodologies to clinical development are highly desirable.
• Understanding of FDA, EMA and ICH regulations and guidelines. Experience working on regulatory submissions is preferred.
• Excellent verbal and written communication skills are essential, along with the ability to work effectively as part of a team.
• Must be able to work independently with minimal supervision.
• Additionally, the ability to travel up to 5% of the time, depending on the business's needs, is required.