Executive Director, Biostatistics

Executive Director, Biostatistics

Our client is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. They are continuing to expand their commercial product portfolio and their research and development pipeline in therapeutic areas that can leverage their unique expertise. Their therapeutic areas of focus include sleep and hematology/oncology – areas in which they have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs. They are looking for the best and brightest talent to join their team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work this is the opportunity for you.

Responsibilities

The Executive Director, Biostatistics will be responsible for leading the Biostatistics function responsible for supporting clinical development within the Biostatistics Department. Biostatistics department includes Statistical Programming and Biostatistics functions supporting development and medical affairs. The Executive Director will provide statistical leadership for biostatistics function in development across all company sites, will support statisticians at Director level and above with direct reports, and will provide statistical expertise and leadership in the development and regulatory approval process efforts for our clients Pharmaceuticals' products. This position reports into VP Biostatistics – Head of Biostatistics Department.

Essential Functions

• Provide statistical leadership for Biostatistics function responsible for supporting clinical development - lead, manage, and develop the employees (>10) in the group.
• Provide statistical expertise and leadership support for statisticians at director and above level.
• Support and assume accountability for planning, organization, and execution of biostatistics activities for clinical development projects and registrations, including protocol development oversight (including participation on Protocol Review Committee), preparation of analysis plans, and delivery of statistical analyses across all development programs.
• Responsible for statistical integrity of proposed and executed analyses across all development programs, and for providing appropriate statistical advice/leadership consistent with prevailing standards for good statistical methodology and regulatory requirements.
• Support appropriate statistical representation in meetings with regulatory authorities to support statistical endpoints, analyses and related issues.
• Lead efforts for process and SOP development within the biostatistics function while engaging cross functional leaders and department employees. Serve as a biostatistics representative on cross functional initiatives.
• Provide expertise, support and leadership in choice, management and issue escalation with respect to biostatistics vendors and CROs.
• Develop collegial and productive relationships with senior leaders across R&D through collaboration, presentations and active participation in addressing clinical development challenges.
• Conduct independent research and resolve statistical methodological issues when needed
• Contribute to the definition and execution of the strategic vision for the Biostatistics Department. Participate as a member of the Biostatistics Leadership Team.
• Manage group budget, own vendor contracts and support monthly accruals.
• Recruit, develop, and retain talents to meet group and department functional goals and business objectives.
• Travel domestically and internationally as required (min once quarterly due to group distribution across sites.)

Minimum Requirements

• PhD in Statistics, Mathematics, or related fields
• A minimum of 10 years of relevant experience with at least 5 years of supervisory experience is required (experience supervising people managers preferred)
• Demonstrated successful leadership experience
• Ability and willingness to travel to California/Pennsylvania sites to ensure sufficient leadership presence and support for teams in both locations
• Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials and regulatory submissions
• Good knowledge of drug development regulations pertinent to statistical analysis
• Extensive experience in contributing to NDAs/BLAs submission and defense
• Excellent writing and communication skills, demonstrated leadership and project management abilities
• Demonstrated ability to present complex issues and proposed solutions to cross functional senior leadership
• Developed organizational awareness and proven ability to influence leaders from other functions