Director, Biostatistics & Clinical Strategy

PMV Pharmaceuticals, Inc.

New Jersey

On-site

USD 275,000 - 345,000

Full time

38 hours ago
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Benefits offered by this job

Health care benefits
Parental leave benefits
Paid Time Off
Employee Stock Purchase Plan
Rewards and recognition program

Job summary

PMV Pharmaceuticals, Inc. seeks an Executive Director of Biostatistics to lead the biostatistics function and set statistical strategy for clinical programs. You will build and manage the internal team, oversee outsourced work, and serve as the statistical voice with Health Authorities and partners.

You will guide trial design, regulatory submissions, data interpretation, and cross-functional collaboration with leadership across clinical operations, data management, and regulatory affairs.

Qualifications

  • PhD or equivalent with extensive leadership in biostatistics.
  • Experience leading NDA/BLA submissions and HA interactions.
  • Strong programming and data analysis capabilities in R/SAS.
  • Proven ability to manage CROs/FSPs and budgets.

Responsibilities

  • Lead statistical strategy for global Health Authority interactions.
  • Oversee outsourced statistical deliverables and budgeting.
  • Build and manage internal biostatistics team and programming.
  • Ensure high-quality validation of programming outputs.
  • Collaborate with cross-functional leadership to guide trials.

Skills

PhD in Statistics/Biostatistics
Leadership in statistical strategy
HA interactions leadership
R or SAS programming
Oncology experience (5+ studies)
People management (5+ years)
CRO/FSP management
Innovative trial designs (adaptive/sef
Data analysis plan development
Medidata RAVE experience
CDISC standards knowledge
GCP/ICH/FDA knowledge
Communication skills
Executive presence

Education

PhD in Statistics/Biostatistics
Masters with 15+ years considered

Tools

Medidata RAVE
R
SAS

Job description

PMV Pharmaceuticals, Inc. seeks an Executive Director of Biostatistics to lead the biostatistics function and set statistical strategy for clinical programs. You will build and manage the internal team, oversee outsourced work, and serve as the statistical voice with Health Authorities and partners.

You will guide trial design, regulatory submissions, data interpretation, and cross-functional collaboration with leadership across clinical operations, data management, and regulatory affairs.

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