Overview

Reporting to the Head of Biostatistics, the Senior Director / Executive Director of Biostatistics acts as statistical lead with accountability for one or more therapeutic the company’s products and study deliverables; Provides strategic input in advancing clinical programs; Offers technical leadership and biostatistical support on the design and implementation of clinical studies; Leads regulatory interactions and submissions to the FDA and other regulatory agencies as biostatistics lead; Coordinates the effort across the different programs to identify, develop and implement departmental standards, applications, processes and training.

Work Model :

Flex: can complete work from home during the pandemic; once return to the office 2-3 days in office to be expected and established with manager

Responsibilities:

  • Ph.D. in Statistics or Biostatistics with 13 years (minimum 15 years for master’s degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
  • Led in NDA/BLA/MAA activities from statistics perspective and experienced in direct regulatory interaction and regulatory inspections
  • Contribute in study level tasks from statistics perspective, including but not limiting to: contribute in study design and sample size determination; author/review statistics section in the protocol, SAP and DMC charter; create/review study randomization files; develop TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings
  • Lead in product level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute to the supporting projects from statistics perspective
  • Work collaboratively within biometrics teams and with teams to meet product timelines for statistical data reporting
  • Translate statistical thinking into strategic input to improve the clinical program
  • Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
  • Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project goals and regulatory statistical and data requirements
  • Lead in developing department standards and research in advanced statistical methodologies
  • Author/review regulatory documents or scientific publications
  • Oversee work by CRO and ensure quality deliverables

Requirements:

  • Experience as product lead statistician and contribute in strategy discussion in cross functional settings; Experienced in managing multiple products and studies
  • Experience in study level work including authoring SAP and TFL specification
  • Familiar with ICH guideline, FDA/EMA/other regulatory authority guidance
  • Experience with mathematical and statistical principles; Experience in statistical methods (longitudinal data analyses, Bayesian method, CRM, adaptive design)
  • Excellent communication and interpersonal skills, with the ability to translate statistical concept to program strategies
  • Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies

The following are some highlighted benefits, but not limited to:

  • Summer and Winter shutdown in addition to generous vacation benefit and many observed company holidays
  • Long-term Incentive and Employee Stock Purchase Plans
  • Paid parental, adoption, and caregiver leave
  • Wellness Offering
  • Deferred compensation for specific roles
  • Fitness reimbursement
  • Tuition Reimbursement
  • Professional development programs