Director, Biostatistics

6 days ago

Princeton, United States PMV Pharmaceuticals, Inc. Full time

Director, Biostatistics & Data Analytics

PMV Pharma is developing first-in-class p53 reactivators for the treatment of cancer. Bringing together leaders in the field to utilize over three decades of p53 biology, PMV Pharma combines biological understanding with pharmaceutical development focus.

PMV Pharmaceuticals is currently looking for an individual to join the company as Director, Biostatistics and Data Analytics. The primary responsibility for this position is to support statistical needs for clinical programs at PMV. This role will report to the Sr. Director, Biostatistics and Data Analytics.

Responsibilities

The Director, Biostatistics & Data Analytics will provide statistical and programming expertise to the development of clinical study designs and in performing data analysis, providing data interpretation and graphical/summary outputs, and contributing to clinical publications and regulatory submissions. This position will contribute to the clinical program, departmental and cross-functional initiatives by working closely with the clinical study team including the medical director, clinical trial management, data management, and other clinical study personnel. Additionally, this role will oversee outsourced activities and deliverables from biostatistics and programming roles, ensuring on time execution and that deliverables are of high quality and met according to the study plan.

  1. Collaborate with the clinical development team in designing clinical trials ensuring that statistical principles are applied appropriately.
  2. Support the clinical development team in global Health Authority interactions as the Biostatistics representative.
  3. Responsible for randomization plans, where applicable.
  4. Collaborate with data management and clinical operations to align statistical analysis plans with data collection procedures and forms.
  5. Facilitate and participate in cross functional review of outsourced statistical deliverables such as statistical analysis plans, TLF shells and specifications, SDTM/ADaM datasets, etc.
  6. Provide scientifically rigorous statistical input and review of clinical protocols, interpretation of statistical results and scientific publications.
  7. Work with stakeholders to define business questions, requirements, timelines, objectives, and success criteria to address needs. Participate in regularly scheduled meetings that require statistical input.
  8. Develop strategies to address health authorities’ inquiries pertaining to biostatistics.
  9. Provide 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.
  10. Maintain and modify in-house code.

Qualifications and Experience

  • Masters in Statistics/Biostatistics with 5+years of directly relevant experience required.
  • Strong R programming skills are required.
  • Experienced in SAS preferred
  • Experience required in oncology therapeutic area
  • Prior experience supporting a BLA or NDA filing and representing biostatistics in interactions with health authorities required.
  • Able to examine relevant data and quickly develop an analysis plan that will answer key business questions.
  • Understanding of clinical or advanced statistics such as regression, time-series forecasting, clustering, decision trees, exploratory data analysis methodology in general, scenario analysis, modeling, optimization, and unstructured data analysis
  • Experience in working with clinical database software and data structures, especially Medidata RAVE
  • Knowledge of and experience with CDISC standards and validation processes required
  • Familiarity with GCP, ICH and FDA requirements required
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills. Ability to work effectively cross-functionally


Benefits

  • PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.


PLEASE, NO PHONE CALLS or AGENCIES

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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