Overview of Role:

The Executive Director of Biostatistics serves as the Biostatistics Lead for multiple oncology projects, providing strategic and technical leadership, as well as statistical support, in the development and execution of statistical strategies, study designs, statistical analyses, and regulatory submissions. They will collaborate with clinical science, regulatory and other functions on clinical development plans, the authorship of key clinical, regulatory, statistical documents, and ensuring the high-quality delivery and accurate interpretation of clinical data.

The Executive Director will develop and implement biostatistics department policies, standards, procedures, and work instructions in coordination with the department leader and other functions. Additionally, they will represent biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies. This role includes direct supervisory responsibilities for internal staff or external consultants.

Role and Responsibilities:

• Serve as the Biostatistics Lead for multiple oncology projects
• Provide strategic and technical leadership, along with statistical support, to clinical development in the design and conduct of late-stage oncology trials
• Provide strategic input and guidance to ensure the high quality of Regulatory Authority documents, including clinical protocols, statistical analysis plans, study reports, briefing books, submissions, and safety reports
• Collaborate with cross-functional teams to ensure accurate interpretation of study results and high-quality study reports and publications
• Write and review sections of meeting packages, and assist in the development and review of other documents required for regulatory submissions and processes
• Lead the assessment and implementation of novel statistical methodologies to drive solutions
• Represent the biostatistics function or biometrics department in cross-functional teams
• Collaborate with the department leader to develop and implement policies, standards and procedures
• Develop strong, collaborative relationships with key business stakeholders, including project leaders in Regulatory, Clinical Development, Clinical Operations, Research and other functions
• Assess and manage CROs and other vendors, including scope-of-work, timelines, deliverables, and budgets
• Stay up to date with FDA and EMA regulations, guidance, emerging trial designs for marketing authorization, and communicate relevant updates to key stakeholders
• Participate in meetings with FDA and other health authorities to ensure alignment on project development
• Provide mentorship and coaching to direct reports to help them reach their full potential
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Ph.D. in Statistics, Biostatistics or equivalent area with 15+ years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (18+ years) can be considered.
• A minimum of 3+ years of experience in team leadership and managing direct reports is required
• 10+ years of experience in oncology clinical trials, including trial design and execution, with a strong background in late-stage clinical trials
• Extensive knowledge of clinical trial development and statistical methodologies related to trial design and execution is required, with experience in late-stage oncology trials and regulatory submissions essential
• Experience in providing statistical support for Medical Affairs and Market Access activities is highly preferred
• Experience interacting with health authorities
• Comprehensive knowledge of ICH, FDA, and GCP regulations and guidelines, with strong, well-rounded technical skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Communicate effectively and articulate complex ideas in an easily understandable way
• Prioritize conflicting demands
• Work in a fast-paced, demanding and collaborative environment

The pay range for this role is $280,000 to $300,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits compensation

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