Principal Biostatistician

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Job Description

About this Role

The Senior Principal Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas, You willparticipatein protocol development, analysis plans and file/report specifications, and reviewstudy setup activities including but not limited to randomization, CRFs and data edits and serveas lead biostatistician for assigned project(s). You willperformstatistical analyses, interpretstatistical results, and prepareclinical study reports including integrated summaries for submissions as appropriate. You will alsocontributes to the long-term growth strategy of the department by participating in process improvement initiatives, keeping abreast of the current statistical methodology development, and providing mentorship to new/junior biostatisticians.

What you'll do
  • Represent Biostatistics on Project Teams; provides statistical expertise to support clinical development objectives and strategy
  • Definestatistical methodology, analyzes data and reports results and contributes to the strategic planning and execution of the clinical development plan for the assigned project; trains and supervises contract statisticians and ensures the quality of their deliverables.
  • Assistresponses to addressing statistical issues are part of regulatory, legal or other challenges to the company’s products or processes; may represent Biostatistics in key meetings as assigned
  • Serve as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel, and acts as an internal consultant, as assigned, on broad statistical issues that impact on the pharmaceutical/Biotechnology industry
  • Participatein approved process improvement initiatives; mentors new/junior biostatisticians; keeps up to date current on statistical methodology and computing development. Conducts modelling and simulations as needed


Qualifications

Requirements:
  • 3+ years experience with PhD in Biostatistics/Statisticsor MS in Biostatistics/Statistics with 5+ years experience
  • Past regulatory interactions preferred
  • Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
  • Ability to develop innovative/creative statistical/technical solutions to complex problems.
  • Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
  • Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

2023838596