Director, Biostatistics

Director, Biostatistics

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.
• 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.