Executive Director, Biostatistics and Data Management

About the Company

Recognized clinical-stage biotechnology (BioTech) therapeutics company

Industry Biotechnology

Type Public Company

Founded 2013

Employees 201-500

Categories

Biotechnology Health Care Pharmaceutical Therapeutics Drug Manufacturing & Research Healthcare Pharmaceuticals Academic Research Medical Care Cancer Awareness Clinical Care Life Sciences Manufacturing Medicine Chemical Products

About the Role

The Company is seeking an Executive Director for Biostatistics and Data Management to take on a pivotal leadership role in the strategic development and implementation of clinical plans. The successful candidate will be responsible for leading the biostatistics strategy across all clinical development projects, providing statistical leadership in various aspects of clinical trials, and ensuring the quality and integrity of statistical deliverables. This role requires a Ph.D. in a relevant field, with a minimum of 15 years' experience in pharmaceutical or biotech clinical drug development, and a strong background in oncology. The Executive Director will also be involved in cross-functional collaboration, overseeing CROs and vendors, and building and mentoring a talented team in biostatistics and data management.

Applicants for the Executive Director position at the company should have a proven track record in the design and analysis of clinical trials, as well as expertise in data analytics and mining. Proficiency in statistical programming languages such as SAS and R is essential, and experience with FDA/ICH guidelines, CDISC standards, and global drug development processes is required. The role demands a candidate with excellent communication skills, the ability to work both independently and as part of a team, and a strong desire to work in a fast-paced, innovative environment. The Executive Director will also be expected to identify and implement innovative statistical methodologies, including the use of generative AI, to enhance the clinical development process and decision-making.

Hiring Manager Title Chief Medical Officer

Travel Percent Less than 10%

Functions

Data Management/Analytics Non-Profit Management Medical Care/Hospital Administration