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Title:Associate Director, Biostatistics
Salary:$125-150K+
Experience:8+
Location:NJ - Parsippany

Description:

We are currently seeking an Associate Director, Biostatistics and Data Management for our Parsippany, NJ location. In this position you will assign and direct biostatistical resources for both clinical research and health outcomes research projects; review documents for appropriateness of methods; prioritize work and provide direction to contracted resources; negotiate with internal colleagues when demand exceeds team capacity; develop performance metrics for department; and oversee selection and annual evaluation of outside vendors and CROs.

Responsibilities:
  • As Associate Director, Biostatistics and Data Management, you will lead the biostatistics and the medical affairs team for data management to ensure appropriate support for all Phase IIIb and Phase IV studies, as well as data mining projects.
  • You will ensure that study design, protocol preparation, and statistical analysis methodologies meet study/project objectives, and are in compliance with regulatory guidance.
  • You will collaborate with the development division biometrics colleagues to ensure worldwide organizational acceptance of statistical design and analyses.
  • You will ensure accuracy of all completed statistical analyses and interpretation in clinical study reports and adhere to timelines for deliverables on all projects.
  • You will direct and manage CROs in the provision of biostatistics and data management support for all assigned projects consistent with timeline expectations.
  • You will ensure the consistency of study designs, parameter algorithms and definitions, analyses and calculations, and reporting formats for all projects.
  • You will actively participate in strategic discussions with therapeutic teams and regularly interact with department senior management, CROs, and outside vendors.
  • You will address specific statistical issues in propose study design and write and defend the “Method of Analysis” section of submissions.

Requirements:
  • Qualified candidates will have a MS in Statistics, Biostatistics, or Mathematics with 10-12 years of pharmaceutical industry experience or PhD in Statistics Biostatistics, or Mathematics with 8-10 years pharmaceutical industry.
  • You will also have full knowledge of advanced statistical analytical methods, clinical trial research, regulatory requirements, programming skills, and statistical software.
  • You will have extensive experience analyzing clinical trial data and experience managing external CRO resources.
  • You will have excellent oral and written communication skills; project planning skills; budgeting skills; demonstrated experience in analyzing clinical trial data; priority setting skills; multi-tasking skills; problem solving skills; eye for detail; exercise good judgment; and work well within team framework.
  • A demonstrated mastery of advanced statistical analytical methods, clinical trial search, regulatory requirements; coding techniques, protocol development and personal computing is also required.
  • 5% travel is required.

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