Executive Director, Biostatistics

pmvpharma • Princeton, NJ

1d • $275,000 - $345,000

About The Position

PMV Pharmaceuticals is seeking an Executive Director, Biostatistics to lead the Biostatistics function and set statistical strategy for clinical programs. This role reports to the SVP, Head of Clinical Development & Medical Affairs. The individual will be responsible for building and managing the internal biostatistics team, serving as the company’s statistical voice with Health Authorities, investigators, and partners. The position involves providing statistical leadership and expertise for clinical development strategy, clinical trials, clinical study design, regulatory submissions, data interpretation, and portfolio decision-making. This role will also shape clinical programs and cross-functional initiatives by collaborating with senior leadership and study teams. Additionally, the Executive Director will set the outsourcing strategy for biostatistics and programming, oversee outsourced activities, and ensure high-quality deliverables.

Requirements

• PhD in Statistics/Biostatistics with 12+ years of directly relevant experience required (Masters with 15+ years considered).
• Prior experience leading statistical strategy & execution for at least one successful NDA/BLA submission required.
• Demonstrated leadership in HA interactions including leading meetings and directly responding to information requests
• Strong programming skills in R or SAS are required, with the ability to set technical direction for programming teams
• Recent experience (within last 5 years) required in oncology (five or more studies)
• 5+ years of people management experience, including building and leading biostatistics teams, ideally in a small or mid-size biotech
• Proven track record managing CROs/FSPs, including vendor selection, contracting input and budget oversight
• Experience with innovative trial designs (e.g., adaptive and seamless designs, dose optimization consistent with FDA Project Optimus)
• Able to examine relevant data and develop an analysis plan that will answer key business questions.
• Experience in working with clinical database software and data structures, especially Medidata RAVE
• Knowledge of and experience with CDISC standards and validation processes required
• Strong knowledge of GCP, ICH and FDA requirements required
• Strong written and verbal communication skills.
• Excellent interpersonal skills.
• Flexible, adaptive and able to work effectively cross-functionally
• Executive presence, with the ability to communicate complex statistical concepts to senior leadership, the Board and external partners

Responsibilities

• Lead statistical strategy for global Health Authority interactions as the senior Biostatistics representative, including Type B/C, End-of-Phase 2 and pre-NDA/BLA meetings.
• Lead strategic scenario planning discussions to guide clinical development and address health authority inquiries.
• Oversee randomization strategy and plans, where applicable.
• Collaborate with data management and clinical operations to align statistical analysis plans with data collection procedures and forms.
• Establish and lead cross functional review of outsourced statistical deliverables such as statistical analysis plans, TLF shells and specifications, SDTM/ADaM datasets, etc.
• Provide scientifically rigorous statistical input and review of clinical protocols, interpretation of statistical results and scientific publications.
• Work with senior stakeholders to define business questions, requirements, timelines, objectives, and success criteria to address needs.
• Provide statistical input to regularly scheduled meetings and governance forums.
• Oversee programming support across development to support delivery of summarized tabular/graphic analyses for inclusion in publications and external scientific meetings and multi-dimensional nonclinical and clinical data analyses.
• Establish standards, SOPs and quality control processes for statistical programming and in-house code.
• Build, hire, develop and manage the internal biostatistics and statistical programming team, including goal setting, performance management and career development.
• Own the biostatistics budget and resource plan across programs, partnering with Finance and Clinical Operations on forecasting.
• Contribute to integrated development plans, portfolio prioritization and due diligence for business development opportunities.
• Represent Biostatistics with investigators, key opinion leaders, DSMBs/IDMCs and external partners.

Benefits

• health care benefits (medical, prescription drugs, dental, and vision insurance)
• paid parental leave benefits
• adoption assistance
• a generous Paid Time Off program
• Employee Stock Purchase Plan
• rewards and recognition program

What This Job Offers

• Job Type: Full-time
• Career Level: Executive