Current jobs related to Head of Biostatistics - California - Penfield Search Partners Ltd

About the Role: Our client, a leading biopharmaceutical organization specializing in Rare Diseases, is on the lookout for a Director or Senior Director of Biostatistics (depending on experience). This pivotal role will oversee statistical operations that support clinical trials, which includes contributing to trial designs, drafting statistical sections of protocols, preparing statistical analysis plans, and interpreting clinical trial data.

Key Responsibilities:

• Lead the statistical and programming team at the product level.
• Provide statistical insights for strategic planning, study design, protocol development, sample size calculations, case report forms, results interpretation, and clinical study reports. Address inquiries from regulatory bodies and develop comprehensive statistical analysis plans (SAPs).
• Guide the study team on all statistical activities and collaborate closely with data management to ensure data integrity.
• Work in conjunction with Clinical Development, Clinical Operations, Clinical Data Management, Pharmacovigilance & Epidemiology, Regulatory Affairs, Project Management, Translational Medicine, and other stakeholders to achieve project goals and timelines.
• Oversee CRO and vendor relationships by establishing procedures through regular communication, setting expectations for deliverables, and ensuring timely and accurate outputs.
• Engage with global health authorities by contributing to documents for submission and participating in discussions as needed.
• Coordinate with both internal and external teams to prepare statistical analyses for Investigational Brochures, Development Safety Update Reports, periodic safety updates, and other safety analyses; actively participate in cross-functional study activities and team meetings.

Company Culture: The organization prides itself on a patient-first approach and maintains high ethical standards. Team members are encouraged to adopt an entrepreneurial spirit, focusing on practical solutions with a sense of ownership.

Qualifications:

• Ph.D. in Statistics or Biostatistics with a minimum of 8 years of relevant experience in the pharmaceutical or biotechnology sector for the Director role; additional experience is required for the Senior Director position.
• Experience with NDA submissions.
• In-depth knowledge of statistical methodologies, contemporary drug development trends, and regulatory frameworks.
• Strong analytical and problem-solving capabilities; adept at independently identifying issues and formulating potential solutions.
• Proficient programming skills in SAS and/or R.
• Ability to thrive in a fast-paced environment as part of a cross-functional team and collaborate effectively with external partners and vendors.

Work Arrangement: This position offers the flexibility of remote work with occasional travel as necessary.