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Title:Manager Biostatistics
Salary:Open
Experience:3+
Location:PA - Swiftwater

Description:
Member of the Medical Affairs Team. Incumbent will provide statistical expertise in the design and reporting of clinical programs and clinical studies, including the production of protocols, Statistical Analysis Plans (SAP), clinical and integrated reports.

Responsibilities:
  • Ensure that study and project-level analyses are completed in line with the agreed Clinical Development Plan (CDP) in order to adequately determine the safety, immunogenicity and efficacy of vaccine products.
  • Provide statistical support to all aspects of Medical Affairs.
  • Provides statistical advice and support to medical affairs programs and post marketing study design as appropriate.
  • Produce/oversee the production of the project and study-level statistical outputs including, but not limited to, synopsis, protocols, SAP, integrated clinical and statistical reports. This may include analyses for presentations internally or externally, meetings with regulatory agencies, or publications.
  • Demonstrated ability to work independently and to work in a multidisciplinary team.

Requirements:
  • PhD in Statistics or related field or equivalent experience; 3-5 years (MS and 5-7 years) relevant industry experience.
  • Demonstrated use of SAS software, especially Base, Statistics, and Graphics.
  • Very good oral and written communication skills.
  • Good interpersonal skills.
  • Author or co-author of publications, a plus.

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