EVP, Head of Biostatistics & Programming with a Specialty Pharma – San Diego, CA

Role Overview for EVP, Head of Biostatistics & Programming with a Specialty Pharma – San Diego, CA

JRG Partners has been exclusively retained to lead the search for an Executive Vice President (EVP), Head of Biostatistics & Programming for a pioneering specialty pharmaceutical company located in the vibrant biotech hub of San Diego, CA. This is a paramount leadership position for a visionary executive poised to shape the future of clinical development and data science within a dynamic, patient-focused organization. Our client is renowned for its innovative approach to developing and commercializing therapies for underserved patient populations with complex diseases. As a key member of the executive leadership team, you will report directly to the Chief Medical Officer and will be instrumental in setting the strategic direction for all biostatistics and statistical programming activities across the company’s portfolio.

This role is not merely about managing a function; it is about providing strategic foresight, statistical leadership, and data-driven insights that will guide critical decisions from early-stage development through to commercialization and life-cycle management. You will be the ultimate authority on statistical matters, ensuring scientific rigor, regulatory compliance, and operational excellence. The ideal candidate will be a strategic thinker with a profound understanding of drug development, a proven track record of successful regulatory submissions, and an inspiring leadership style. You will inherit a talented team and be responsible for its growth, mentorship, and development, fostering a culture of innovation, collaboration, and unwavering commitment to quality. Your influence will extend across the entire organization, collaborating closely with Clinical Development, Regulatory Affairs, Clinical Operations, Medical Affairs, and Commercial teams to ensure cohesive and successful program execution. This is a unique opportunity to make a tangible impact on the lives of patients by bringing transformative therapies to market.

Key Responsibilities of EVP, Head of Biostatistics & Programming with a Specialty Pharma – San Diego, CA

The EVP, Head of Biostatistics & Programming will be accountable for the following key areas:

Strategic and Functional Leadership

• Develop and execute the long-term vision and strategy for the Biostatistics and Programming functions, ensuring alignment with overall corporate goals and R&D objectives.
• Serve as the primary statistical expert on the senior leadership team, providing critical insights and guidance on development strategies, portfolio decisions, and risk assessment.
• Champion the use of innovative statistical methodologies, including adaptive trial designs, Bayesian methods, and real-world evidence integration, to accelerate clinical development timelines and increase the probability of success.
• Establish and maintain departmental standards, policies, and Standard Operating Procedures (SOPs) to ensure the highest level of quality, integrity, and compliance in all statistical deliverables.

Clinical Development and Regulatory Strategy

• Provide executive oversight for all statistical aspects of clinical development programs from Phase I through Phase IV, including protocol design, statistical analysis plans (SAPs), and data interpretation.
• Lead the statistical strategy for regulatory interactions and submissions globally. You will be the lead statistical representative in key meetings with health authorities, including the U.S. Food and Drug Administration (FDA), EMA, and PMDA.
• Oversee the preparation and review of statistical sections of all clinical and regulatory documents, such as clinical study reports (CSRs), INDs, NDAs, BLAs, and responses to regulatory agency queries.
• Ensure that all clinical trials are designed with robust statistical power, appropriate endpoints, and valid methodologies to meet regulatory and commercial objectives.

Team and Operations Management

• Lead, mentor, and develop a world-class team of biostatisticians and statistical programmers, fostering a culture of excellence, continuous learning, and professional growth.
• Manage departmental budgets, resource allocation, and long-range planning to effectively support the entire clinical portfolio.
• Oversee the selection and management of Contract Research Organizations (CROs) and other external vendors, ensuring high-quality, on-time, and within-budget delivery of outsourced statistical services.
• Drive operational excellence by implementing state-of-the-art technologies, systems, and processes for data analysis and reporting, including the adoption and governance of CDISC standards (SDTM, ADaM).

Requirements for the EVP, Head of Biostatistics & Programming with a Specialty Pharma – San Diego, CA

To be considered for this critical leadership role, candidates must possess the following qualifications:

Educational & Professional Experience

• A Ph.D. in Biostatistics, Statistics, or a closely related quantitative field is required.
• A minimum of 18+ years of progressive experience in the pharmaceutical or biotechnology industry, with a deep and thorough understanding of the entire drug development lifecycle.
• At least 10 years of experience in a significant leadership capacity, with demonstrated success in building, managing, and mentoring high-performing biostatistics and programming teams.
• A proven track record of leading the statistical strategy for successful NDA/BLA/MAA submissions and approvals in major markets.

Technical and Strategic Expertise

• Recognized as an expert in clinical trial design, statistical modeling, and data analysis methodologies across various therapeutic areas. Experience in specialty pharma areas such as oncology, rare diseases, or immunology is highly desirable.
• Extensive experience interacting directly with the FDA and other global regulatory authorities, serving as the lead statistician in key negotiations and meetings.
• In-depth knowledge of ICH/GCP guidelines, regulatory requirements, and industry best practices for data management and statistical analysis.
• Proficiency with statistical software (e.g., SAS, R) and a comprehensive understanding of data standards (CDISC).

Leadership Competencies

• Exceptional strategic thinking and problem-solving skills, with the ability to translate complex statistical concepts into actionable business strategies.
• Outstanding communication and interpersonal skills, capable of influencing and collaborating effectively with internal stakeholders at all levels, including the Board of Directors, as well as external key opinion leaders and regulatory bodies.
• Demonstrated ability to thrive in a fast-paced, innovative, and science-driven environment.
• A strong sense of integrity, ethics, and a deep commitment to patient outcomes.

Benefits & Perks Offered

Our client is committed to attracting and retaining top-tier executive talent and offers a comprehensive and highly competitive compensation and benefits package, including:

• Executive Compensation: A highly competitive base salary, significant annual performance-based bonus, and a substantial long-term equity incentive package (stock options/RSUs).
• Comprehensive Health & Wellness: Premium medical, dental, and vision insurance plans for you and your dependents, along with company-sponsored wellness programs and a flexible spending account (FSA).
• Retirement Planning: A robust 401(k) retirement plan with a generous company match to help you plan for your future.
• Work-Life Integration: A generous paid time off (PTO) policy, paid company holidays, and a supportive culture that values work-life balance.
• Professional Development: A dedicated budget for executive coaching, attending industry conferences, and pursuing continuous education to stay at the forefront of the field.
• Relocation: A comprehensive executive relocation package is available for the successful candidate and their family to move to the beautiful San Diego area.

How to Apply

This is a confidential, retained search conducted by JRG Partners. If you are a transformative biostatistics leader ready to take on a career-defining challenge, we encourage you to apply. To be considered for this pivotal executive role, please submit your curriculum vitae and a detailed cover letter outlining your qualifications and interest. JRG Partners is the exclusive search firm for this engagement. You can learn more about our expertise in recruiting top-tier executives in this sector by visiting our Life Sciences practice area page. We are an equal opportunity employer and value diversity at our company and our clients. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.