Sr Biostatistician

4 - 7 years

4 - 7 Lacs

Posted:2 days ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Sr Biostatistician

Roles and Responsibilities

  • Provide support across all assigned statistical tasks during the lifecycle of a clinical trial project, from protocol development to the Clinical Study Report (CSR).
  • Prepare

    Statistical Analysis Plans (SAPs)

    , including the development of well-presented mock-up displays for tables, listings, and figures.
  • Coordinate the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high-quality work.
  • Provide independent review of project work produced by other biostatisticians in the department.
  • Create or review programming specifications for analysis datasets, tables, listings, and figures.
  • Review

    SAS annotated case report forms (CRFs)

    and other study documentation to ensure all data is captured to support the planned analysis.
  • Conduct and participate in the verification and quality control of project deliverables.
  • Serve as the biostatistics representative on project teams, managing scheduling, time constraints, and proactively communicating any difficulties.
  • Monitor progress on study activities

    against milestones and ensure project timelines are met.
  • Provide statistical programming support as needed.
  • Support business development activities by contributing to proposals and budgets.
  • Coach and mentor other Biostatistics staff.
  • Follow applicable

    SOPs, WIs

    , and relevant regulatory guidelines (

    ICH

    ).
  • Maintain well-organized and up-to-date project documentation to ensure inspection readiness.

Skills Required

  • A graduate degree in biostatistics or a related discipline.
  • Proven experience in clinical trials.
  • Proficiency in programming

    .
  • Ability to apply knowledge of

    statistical design, analysis, relevant regulatory guidelines

    , and programming techniques utilized in clinical research.
  • Experience across all statistical tasks required to support clinical trials, from protocol to CSR.
  • Excellent written and verbal communication skills.
  • The ability to effectively communicate complex statistical concepts.

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Syneos Health

Biotechnology Research

Morrisville NC

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