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Statistical Programmer

Posted over 1 year agoViewed

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💎 Seniority level: Senior, 7+ years

🔍 Industry: Pharmaceutical / biotechnology

🗣️ Languages: English

⏳ Experience: 7+ years

Requirements:
  • Typically requires a bachelor's degree in computer science, statistics, or related fields.
  • 7+ years of experience in pharmaceutical/biotechnology companies.
  • A master's degree may substitute for some years of experience.
  • Experience as a study lead programmer or overseeing CRO performance is required.
  • Expert in SAS with extensive knowledge of CDISC standards including SDTM, ADaM, and Pinnacle 21.
  • Ability to work in a fast-paced environment with limited supervision.
  • Knowledge of EDC, data management applications, and ICH/GCP regulations.
  • Strong collaboration skills.
Responsibilities:
  • Serve as statistical programming representative in study management teams and regulatory interactions.
  • Collaborate with biometrics and clinical development teams to build data and analysis standards.
  • Ensure quality of all statistical programming deliverables.
  • Review study protocol, CRF, SAP, DTAs, TFL shell, and other study documentation.
  • Perform, review, and QC ADaMs and TFLs for quality and accuracy.
  • Work with Statisticians on exploratory analyses and data reviews.
  • Contribute to statistical programming deliverables for regulatory submissions.
  • Develop and maintain necessary programming macros or tools for programming needs.
  • Support statistical analyses, clinical study reports, regulatory documents, and publications while performing QC activities.
  • Support cross-functional activities related to biometrics and clinical program development.
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