JRG Partners is proud to be the exclusive recruitment partner for a leading, publicly-traded biopharmaceutical company at the forefront of developing innovative therapies for patients with critical unmet medical needs. Our client, headquartered in the vibrant biopharma hub of Princeton, NJ, is seeking a visionary and strategic leader to join their executive team as the Executive Vice President (EVP), Head of Biostatistics. This is a rare opportunity to shape the statistical foundation of a dynamic organization, influence the entire drug development pipeline, and ultimately bring life-changing treatments to market. The successful candidate will be a thought leader with a profound understanding of statistical science, regulatory landscapes, and drug development, capable of building and mentoring a world-class biostatistics function.
This executive position reports directly to the Chief Medical Officer and is a critical member of the R&D leadership team. You will be responsible for providing the strategic direction, scientific oversight, and operational leadership for all biostatistics activities across the company’s portfolio. This includes everything from early-phase clinical trial design to late-stage submissions and post-marketing support. We are looking for an individual who can not only ensure statistical rigor and data integrity but also serve as a strategic partner to cross-functional teams, providing innovative statistical solutions to complex scientific challenges. Your leadership will be instrumental in driving data-driven decision-making and ensuring the successful development and commercialization of our client’s groundbreaking therapies.
Role Overview for EVP, Head of Biostatistics with a Public Biopharma – Princeton, NJ
The EVP, Head of Biostatistics is the most senior statistical leader within the organization, tasked with establishing and executing the global biostatistical vision and strategy. This role provides leadership and guidance on all statistical matters, ensuring that clinical development programs are strategically sound, efficiently designed, and properly analyzed to meet regulatory and commercial objectives. You will be accountable for the quality, integrity, and timeliness of all statistical deliverables, from study protocols and statistical analysis plans (SAPs) to clinical study reports (CSRs) and integrated regulatory submission documents. As a key executive, you will represent the biostatistics function in high-level corporate meetings, governance committees, and interactions with regulatory agencies worldwide. You will be expected to foster a culture of scientific excellence, innovation, and collaboration, building a high-performing team of statisticians and programmers. Your influence will extend beyond your immediate department, as you will provide expert statistical consultation to other functions, including clinical development, regulatory affairs, medical affairs, and business development. This role demands a unique blend of deep technical expertise, strategic foresight, exceptional leadership skills, and the ability to communicate complex statistical concepts to diverse audiences effectively.
Key Responsibilities of EVP, Head of Biostatistics with a Public Biopharma – Princeton, NJ
Strategic Leadership & Vision
Develop and implement the long-term strategic vision for the global biostatistics function, ensuring alignment with overall R&D and corporate goals. Provide executive oversight for all biostatistical and statistical programming activities across all therapeutic areas and stages of development.
Clinical Program Strategy
Serve as the lead statistical expert on clinical development teams, providing strategic input into the design of clinical development plans (CDPs), individual clinical trials, and integrated evidence generation strategies. Champion the use of innovative and efficient trial designs, such as adaptive designs, master protocols, and Bayesian methodologies, where appropriate.
Team Development & Management
Lead, mentor, and develop a global team of biostatisticians and statistical programmers. Foster a culture of excellence, accountability, and continuous learning. Oversee resource planning, allocation, and talent management, including recruitment, retention, and professional development of staff. Manage and oversee CROs and other external vendors providing statistical services.
Regulatory Strategy & Interaction
Lead the statistical strategy for regulatory submissions (e.g., IND, NDA, BLA, MAA). Act as the primary statistical representative in key meetings with health authorities, such as the FDA and EMA. Oversee the preparation of statistical sections of all regulatory submission documents, ensuring they are of the highest quality and scientifically robust.
Technical & Methodological Oversight
Ensure the application of rigorous, state-of-the-art statistical methods across all projects. Maintain a deep understanding of current and emerging statistical methodologies and regulatory guidelines. Provide expert guidance on complex statistical issues and oversee the development of departmental SOPs, best practices, and standards. Demonstrated expertise in regulatory requirements and guidelines, including deep familiarity with FDA’s guidance on statistical principles for clinical trials, is paramount.
Data Integrity & Quality Assurance
Be ultimately accountable for the statistical integrity of clinical trial data, analyses, and interpretation. Ensure that all statistical work is conducted in compliance with GCP, ICH guidelines, and other applicable regulations. Oversee the development and implementation of quality control processes for statistical deliverables.
Cross-Functional Collaboration
Serve as a key strategic partner to leaders in Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, Pharmacovigilance, and Medical Affairs. Ensure seamless collaboration and communication to achieve program milestones and corporate objectives.
Fiscal & Operational Management
Develop and manage the departmental budget, ensuring efficient use of resources. Oversee the selection and management of CROs and other vendors for statistical and programming support, ensuring high-quality and timely deliverables.
Requirements for the EVP, Head of Biostatistics with a Public Biopharma – Princeton, NJ
Educational Background
A Ph.D. in Biostatistics, Statistics, or a closely related quantitative field is required.
Executive Experience
A minimum of 15-20 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 10 years in a leadership role managing biostatisticians and programmers. Proven experience at a Vice President level or higher is strongly preferred.
Drug Development Expertise
Extensive, hands-on experience across all phases of drug development (Phase I-IV), with a proven track record of successful regulatory submissions and approvals in the US and Europe. Experience across multiple therapeutic areas is highly desirable.
Regulatory Acumen
Deep expertise in global regulatory requirements and guidelines (FDA, EMA, ICH). Must have direct experience representing a sponsor in key interactions with health authorities.
Leadership Skills
Demonstrated ability to lead, influence, and motivate a diverse, high-performing team. A track record of developing talent and building effective organizational structures. Exceptional strategic thinking, problem-solving, and decision-making skills.
Technical Proficiency
Mastery of statistical principles and methodologies in clinical trial design and analysis. Strong knowledge of statistical software (e.g., SAS, R) and data standards (e.g., CDISC, SDTM, ADaM).
Communication & Interpersonal Skills
Outstanding written and verbal communication skills. The ability to articulate complex statistical concepts clearly and persuasively to both technical and non-technical audiences. Proven ability to build strong collaborative relationships with internal and external stakeholders.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent and offers a highly competitive compensation and benefits package, including:
Executive Compensation
A competitive base salary, annual performance-based bonus, and a significant long-term incentive package (stock options/RSUs).
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance for you and your eligible dependents. Wellness programs and resources to support your physical and mental health.
Retirement Savings
A robust 401(k) plan with a generous company match.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and company holidays.
Professional Growth
A strong commitment to professional development, with support for attending major conferences, workshops, and continuing education.
Relocation Assistance
A comprehensive relocation package is available for the ideal candidate.
How to Apply
JRG Partners is the exclusive search firm retained for this critical executive leadership position. To be considered for this confidential opportunity, please submit your CV and a cover letter detailing your qualifications and interest in the role. We are committed to a thorough and discreet recruitment process.
