PMV Pharma is pioneering the development of first-in-class p53 regulators for cancer treatment. By bringing together leaders in the field and leveraging over three decades of p53 biology research, PMV Pharma integrates unique biological insights with a strong focus on pharmaceutical development.
Job Description:
PMV Pharmaceuticals is currently looking for an individual to join the company as Executive Director, Biostatistics. The primary responsibility for this position is to lead the Biostatistics function and set statistical strategy for clinical programs at PMV. This role will report to the SVP, Head of Clinical Development & Medical Affairs. As PMV’s senior statistical leader, this person will build and manage the internal biostatistics team and serve as the company’s statistical voice with Health Authorities, investigators and partners. This person will provide statistical leadership and expertise in support of:clinical development strategy, clinical trials, clinical study design development including SAPs, sample size calculation and power estimationregulatory submissions (including NDA/BLA filings) and Health Authority interactionsdata interpretation, analysis and reporting needsportfolio and program decision-making, including go/no-go criteria and indication prioritization This position will shape the clinical program, departmental and cross-functional initiatives by working closely with senior leadership and the study team including the medical director, clinical trial management, data management, regulatory affairs and other clinical study personnel. Additionally, this role will set the outsourcing strategy for biostatistics and programming (including CRO/FSP selection and budget) and oversee outsourced activities and deliverables from biostatistics and programming roles, ensuring on time execution and that deliverables are of high quality through validation activities and are met according to the study plan.
Key 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.
Qualifications:- 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 RAVEKnowledge of and experience with CDISC standards and validation processes requiredStrong knowledge of GCP, ICH and FDA requirements requiredStrong 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
- Salary Range & Benefits
The expected salary range for this position is $275K to $345K representing the potential low and high ends. Actual salaries may vary depending on factors such as experience, skillset, and performance. The salary range listed is just one component of our total compensation package. PMV Pharma also provides a competitive suite of benefits, including health care benefits (medical, prescription drugs, dental, and vision insurance), paid parental leave benefits and adoption assistance, a generous Paid Time Off program, Employee Stock Purchase Plan, rewards and recognition program, and much, much more.health care benefits (medical, prescription drugs, dental, and vision insurance)paid parental leave benefits and adoption assistancea generous Paid Time Off program Employee Stock Purchase Planrewards and recognition programand much, much more Living the PMV Values
Success at PMV is measured not only by what we achieve, but also by how we achieve it. Employees are expected to: Put patients and science at the center of decisions. Demonstrate integrity, transparency, and accountability. Collaborate across functions with respect and professionalism. Embrace diverse perspectives and continuous learning. Take ownership, execute with excellence, and deliver results. These behaviors are considered in hiring, development, performance evaluation, promotion, and leadership decisions. PMV Pharmaceuticals is an Equal Opportunity Employer, and all applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
