Director, Biostatistics

1 month 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.


This person will provide statistical expertise in support of

  • clinical trials, clinical study design development including SAPs, sample size calculation and power estimation
  • regulatory submissions and Health Authority interactions
  • data interpretation, analysis and reporting needs


This position will contribute to the clinical program, departmental and cross-functional initiatives by working closely with the study team including the medical director, clinical trial management, data management, regulatory affairs 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 through validation activities and are met according to the study plan.

  1. Support the clinical development team in global Health Authority interactions as the lead Biostatistics representative.
  2. Participate in strategic scenario planning discussions to guide clinical development and address health authority inquiries.
  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. 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.
  9. Maintain and modify in-house code.

Qualifications and Experience

  • Masters in Statistics/Biostatistics with 5+years of directly relevant experience required.
  • Prior experience leading statistical strategy & execution for NDA/BLA submission required.
  • Direct involvement in HA interactions including attending meetings and directly responding to information requests
  • Strong programming skills in R or SAS are required
  • Recent experience (within last 5 years) required in oncology (five or more studies)
  • 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 RAVE
  • Knowledge of and experience with CDISC standards and validation processes required
  • Strong knowledge of GCP, ICH and FDA requirements required
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills. Flexible, adaptive and able 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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