Vice President, Biostatistics

Job Description

Job Description

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit  

Job summary

The Vice President, Biostatistics is the functional leader accountable for the design, integrity, and delivery of all statistical strategy and outputs across INOVIO’s clinical development programs. This role is responsible and accountable for establishing Biostatistics as a core function in clinical and scientific decision-making within the organization. This position will ensure that all clinical data and their interpretation are clear, defensible, and regulatory-ready that directly inform development and regulatory strategy, and where appropriate, business decisions. This position is currently structured as an individual contributor role and requires a hands-on leader who will directly perform critical statistical work while providing oversight and strategic direction for outsourced statistical activities conducted by CROs, consultants, and other external partners.

Essential job functions and duties

• Define and lead the enterprise Biostatistics strategy across all development programs, ensuring alignment with clinical development objectives, regulatory requirements, portfolio priorities, and corporate goals. 
• Serve as the principal statistical expert and accountable leader for all statistical methodologies, analyses, assumptions, interpretations, and deliverables supporting INOVIO’s clinical development programs
• Provide hands-on statistical leadership for the design, execution, analysis, and interpretation of clinical trials across all phases of development, including protocol development, endpoint selection, sample size determination, interim analyses, randomization methodologies, and novel study designs, as appropriate. 
• Personally perform, review, and approve complex statistical analyses and key deliverables while directing activities performed by CROs, consultants, statistical programmers, and other external partners. This role requires both strategic leadership and direct technical contribution.
• Lead the development, review, and approval of Statistical Analysis Plans (SAPs), analysis specifications, tables, listings and figures, Clinical Study Reports, integrated summaries, regulatory submission documents, scientific manuscripts, abstracts, posters, and presentations. 
• Serve as the primary statistical representative in interactions with health authorities, including FDA, EMA, PMDA, and other regulatory agencies, and provide statistical leadership for IND, NDA, BLA, and other regulatory submissions. 
• Ensure all statistical analyses, datasets, documentation, and supporting materials are scientifically rigorous, defensible, reproducible, compliant with applicable regulatory standards, and inspection-ready. 
• Anticipate, assess, and communicate statistical, operational, and regulatory risks and develop mitigation strategies that support successful clinical development and registration objectives. 
• Represent Biostatistics as a core member of clinical and program leadership teams, partnering closely with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, Statistical Programming, Medical Affairs, Quality, and other functions to ensure integrated execution of development strategies. 
• Translate complex statistical methodologies, analyses, and clinical results into clear, actionable recommendations that support scientific, regulatory, and business decision-making at all levels of the organization. 
• Establish and maintain statistical standards, procedures, governance models, and best practices that ensure consistency, quality, efficiency, and compliance across all programs.
• Define and oversee the operational model for Biostatistics, including effective utilization of internal resources, CROs, consultants, and technology platforms to support portfolio execution, quality, timelines, and budget objectives. 
• Select, manage, and evaluate CROs, vendors, consultants, and other external partners to ensure high-quality deliverables, adherence to timelines, regulatory compliance, and cost-effective execution. 
• Provide strategic leadership for future Biostatistics capability development, including assessment of organizational needs, identification of capability gaps, recruitment of talent, and development of function-specific processes and policies as business needs evolve. 
• Maintain current knowledge of emerging statistical methodologies, drug development trends, regulatory guidance, and industry best practices, and evaluate innovative approaches that may enhance clinical development efficiency, decision-making, and regulatory success. 

Minimum requirements

• Advanced degree in statistics or biostatistics (master’s degree or higher).
• 15+ years’ experience in biometrics with at least 10 years in the pharmaceutical or biotechnology industry, including responsibility for statistical strategy and execution across all phases of clinical development.
• Demonstrated experience leading statistical support for regulatory submissions and interactions with global health authorities, including FDA, EMA, and PMDA.
• Expert knowledge of clinical trial design, statistical methodology, and analysis planning, including endpoint selection, sample-size determination, interim analyses, randomization, and innovative trial designs.
• Demonstrated ability to independently perform and critically review complex statistical analyses and key statistical deliverables.
• Strong understanding of regulatory requirements and industry standards, including ICH guidance and CDISC standards.
• Proven ability to influence clinical development and regulatory strategy through scientific expertise and data-driven insights.
• Effective communication skills, written and oral, with the ability to translate complex statistical concepts for executive leadership, regulators, and cross-functional stakeholders.
• Demonstrated success leading through influence in a matrixed environment; prior people-management experience is a plus.
• Proficiency with statistical software and analytical tools, including SAS and S-plus/R.
• Ability to thrive in a fast-paced biotechnology environment while balancing strategic leadership with hands-on execution.

Disclaimer

INOVIO Pharmaceuticals, Inc. is an Equal Employment Opportunity Employer, including but not limited to veterans and individuals with disabilities. We prohibit discrimination of any kind. In keeping with our policy, we recruit, hire, train, and promote the most qualified individuals for all job titles, and we provide equal opportunities to all employees and applicants for employment.

A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer. 

Important notice to employment businesses/agencies

INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.