Biotech/Pharmaceutical

Sr. Director, Biostatistics

Permanent

Penfield Search Partners

Contact: Barbara Day – 201.784.9028 – bday@penfieldsearch.com

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at company. Join us as a Senior Director, Statistics in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.  As a Senior Director working in the Statistical and Quantitative Sciences-Gastroenterology (SQS-GI) group that is part of the larger SQS organization in company’s Data Sciences Institute, you will be empowered to contribute to statistical and data-sciences-related innovation, driving quantitative drug-development strategies to advance the GI therapeutic area unit (TAU) pipeline at company.

Position Objectives:

  • People manager role (reporting to the therapeutic area (TA) Statistics Head) supervising 3-5 statisticians in addition to being Statistics Lead for TAU drug-development programs
  • Lead quantitative strategy for the TAU development projects from Phase 1 to Phase 4 (including support for Clinical Pharmacology trials) and maximize statistical contributions to clinical, regulatory, medical affairs and commercial functions
  • Implement technical rigor and promote data-driven decision-making and efficient approaches for trial design and clinical development plans
  • Contribute to creating a work environment that is competent, transparent and empathetic
  • Help develop strategies for statistics-related technologies, processes, best practices and standards
  • Promote a culture that is diverse, equitable and inclusive

Position Accountabilities:

  • Program Statistics Lead for TAU development programs
  • Supervise 3-5 statisticians
  • Partner with TAU functional stake-holders driving productive collaborations, to maximize statistical contributions to clinical, regulatory, and commercial development strategies 
  • Ensure adequate statistical support for high quality and timely delivery on statistical activities for TAU development projects supported by direct reports
  • Promote innovative clinical development plans, efficient trial designs and cutting-edge analysis methodologies in clinical trials
  • Serve as a delegate for the TA Statistics Head, as needed, in interactions with senior stake-holders
  • Contribute to keeping the organization current on data-science and statistical methodologies relating to drug development and regulatory requirements

Qualifications:

  • PhD or MS in Statistics or Biostatistics
  • 12+ years of pharmaceutical/biotech experiences with a PhD degree and 15+ years with an MS degree
  • Excellent technical and computational skills particularly in early development
  • Outstanding communication skills and excellent technical writing skills
  • Kind and empathetic problem-solver who can provide strategic and technical guidance while inspiring direct reports to be innovative
  • Must have strong leadership skills with the ability to mentor and motivate direct reports. Contributes to creating a culture that is nurturing and safe.  Takes stand on important issues in productive, respectful way.
  • Solid background and knowledge of statistical methodologies for TAU-run clinical trials
  • Interact effectively with regulatory authorities
  • Ability to negotiate and influence at all levels of the organization, without direct hierarchical authority, and affect change across organizational boundaries.
  • Ability to collaborate effectively with peers, within global teams and in communicating with senior leadership.

Tagged as: Sr. Director, Biostatistics