Head of Biostatistics

2 weeks ago

Princeton, New Jersey, United States PMV Pharmaceuticals, Inc. Full time

Director, Biostatistics & Data Analytics

PMV Pharmaceuticals, Inc. is at the forefront of developing innovative p53 reactivators aimed at treating cancer. Our team comprises experts in the field, leveraging over thirty years of p53 biological research to merge scientific insights with a strong focus on pharmaceutical development.

We are seeking a qualified individual to take on the role of Director, Biostatistics and Data Analytics. This position is crucial for addressing the statistical requirements of our clinical programs. The selected candidate will report directly to the Senior Director of Biostatistics and Data Analytics.

The responsibilities of this role include:

  • Providing statistical expertise for clinical trials, including the development of clinical study designs, statistical analysis plans (SAPs), sample size calculations, and power estimations.
  • Supporting regulatory submissions and facilitating interactions with health authorities.
  • Interpreting data and fulfilling analysis and reporting requirements.

This position will play a vital role in our clinical programs and cross-departmental initiatives by collaborating closely with various team members, including the medical director, clinical trial management, data management, regulatory affairs, and other clinical study staff.

Moreover, the Director will oversee outsourced biostatistics and programming activities, ensuring timely execution and high-quality deliverables through thorough validation processes in accordance with the study plan.

  1. Act as the lead biostatistics representative for global health authority interactions.
  2. Engage in strategic planning discussions to inform clinical development and respond to health authority inquiries.
  3. Manage randomization plans as necessary.
  4. Work alongside data management and clinical operations to ensure alignment between statistical analysis plans and data collection methodologies.
  5. Facilitate cross-functional reviews of outsourced statistical deliverables, including statistical analysis plans, TLF shells, specifications, and SDTM/ADaM datasets.
  6. Provide rigorous statistical input and review for clinical protocols, statistical results interpretation, and scientific publications.
  7. Collaborate with stakeholders to define business questions, requirements, timelines, objectives, and success criteria.
  8. Offer programming support to deliver summarized tabular and graphic analyses for publications and scientific meetings, as well as multi-dimensional analyses of nonclinical and clinical data.
  9. Maintain and update in-house programming code.

Qualifications and Experience

  • A Master's degree in Statistics or Biostatistics with a minimum of 5 years of relevant experience.
  • Proven experience in leading statistical strategy and execution for NDA/BLA submissions.
  • Direct involvement in health authority interactions, including attending meetings and responding to information requests.
  • Strong programming proficiency in R or SAS is essential.
  • Recent experience in oncology, having worked on five or more studies within the last five years.
  • Able to analyze relevant data and develop comprehensive analysis plans to address key business questions.
  • Experience with clinical database software and data structures, particularly Medidata RAVE.
  • Familiarity with CDISC standards and validation processes is required.
  • Strong understanding of GCP, ICH, and FDA regulations is necessary.
  • Excellent written and verbal communication skills.
  • Exceptional interpersonal skills, with the ability to work effectively across functions.

Benefits

  • PMV Pharmaceuticals offers a competitive medical benefits package, a generous paid time off policy, competitive salaries, an Employee Stock Purchase Plan, an Employee Referral Program, and more.

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.

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