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Statistical Programmer

Statistical Programmer

cGxPServeSan Francisco, California, USA
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Responsibilities :

  • Provide statistical programming support to generate SDTM and ADaM datasets tables listings and figures for individual studies and ISS / Client to FDA EMA and other worldwide regulatory agencies.
  • Participate in the review of statistical analysis plans and TLF specifications.
  • Review or annotate CRFs for SDTM mapping review / author SDTM / ADaM dataset specifications.
  • Review and comment on CRFs vendor data transfer specifications (DTS) edit checks and other study data related documents.
  • Support in the preparation of study reports regulatory submissions and annual safety update reports.
  • Perform additional analysis and validation for data checking publication presentation poster and ad hoc analysis.
  • Work with CRO statistical programmers and perform statistical programming vendor oversight.
  • Contribute to Biometrics SOPs and work instructions related to EDC studies FDA requests and statistical programming processes.
  • Contribute to department process improvement initiatives.
  • Support department infrastructure builds up by developing validating and testing the macros utilities and tools.
  • Keep abreast of literature and advancements in SAS.

Requirements :

  • Bachelors or masters degree in biostatistics computer science or related fields masters degree preferred.
  • At least 8 years of relevant experience including as a Lead Statistical Programmer in the biotech or pharmaceutical industry.
  • The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
  • Proficient of SAS programming in a regulated clinical research environment.
  • Experience of programming and validation of SDTM and ADaM data sets tables figures and listings.

    • Key Skills

    Business Development,Customer Service,Attorney,CISSP,Data Analysis

    Employment Type : Full-time

    Experience : years

    Vacancy : 1

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    Statistical Programmer • San Francisco, California, USA