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 estimation
regulatory submissions (including NDA/BLA filings) and Health Authority interactions
data interpretation, analysis and reporting needs
portfolio 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…