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Manager, Biostatistics

  • Location: New Jersey
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted about 1 month ago

  • Sector: Life Sciences
  • Contact: Alicia Licht
  • Expiry Date: 02 October 2022
  • Job Ref: JN -082022-473115

Groweing Sponsor client near Princeton, NJ is looking for a Manager of Biostatistics . Ideally this person can come onsite 1x per week, but client can consider remote on East Coast with ability for occasional travel.

Responsibiltiies:

  • Manages or leads biostatistics assignments on multiple projects.
  • Remains informed of new developments in biostatistics and programming that are relevant to the industry.
  • Establishes and implements biostatistics and programming standards and complies with regulatory requirements among project team members and across studies.
  • Programming in SAS and/or R for data analysis and reporting.
  • Assists with statistical quality assurance review.
  • Reviews deliverables before transfer to either internal or external clients.
  • Performs statistical services to achieve timely, quality, and cost-effective deliverables including SAP, TLF shells and dataset spec development.
  • Participates in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines related to statistics and programming.
  • Hands-on programming for TLF deliverables required statistical inference.

Requirements:

  • MS degree in statistics or equivalent training required, PhD preferred
  • A minimum of 6years of industry or CRO experience required
  • Experience leading statistical projects in the pharmaceutical industry, demonstrated by the ability to independently function as the point of contact for statistics over all phases of clinical trials
  • Proficient in industry standards, medical terminology, and clinical trial methodologies
  • Possesses project management skills within the biostatistics function
  • Regulatory (FDA and EMA) submission experience is not required but is considered valuable for an optimal candidate

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