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Senior Statistical Programmer/Analyst - Remote

ClinChoice Fort Washington, PA
  • Posted: over a month ago
  • Full-Time
Job Description

We are seeking a talented Senior Statistical Programmer/Analyst  (REMOTE) to work on client projects in our office or remotely. It's a great opportunity to work across clinical trial phases and multiple therapeutic areas in a cohesive team environment. Duties include but are not limited to:

  • Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines and create tables, listings and figures for clinical study reports with no supervision;
  • Independently create or validate SDTM specifications and datasets, as well as, ADaM specifications and datasets with no supervision;
  • Create FDA submission packages, e.g., define.xml or define.pdf following FDA/CDISC guidelines or sponsor requirements with no supervision;
  • Serve as point of contact (POC) of programming with statisticians for statistical input and answer technical questions and resolve technical issues from cross functional members;
  • Follow and reinforce regulatory agency requirements provide technical guidance; contributing to department initiatives and project deliverables, timelines and resources;

Requirements

  • Bachelor’s/Master’s degree in Statistics, Computer Science, Electrical and Computer Engineering, Biotechnology or related scientific disciplines with 5+ years of clinical programming (SAS) experience;
  • Expert-level in decoding programming logic and code and able to explain to team members; Database programming experience is a plus;
  • In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology;
  • Good understanding of clinical drug development process;
  • Strong communication and coordination skills; Independently communicate with global teams;
  • Detail-oriented and ability to learn and adapt to changes;
  • Proficient in Microsoft Office Suite, e.g. Word, Excel, PowerPoint, etc.

    For further consideration, please apply on at 
    https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=8845c674-0db3-40c7-9d26-eb01472c090e&ccId=1586553123155066_451&jobId=327806&lang=en_US&source=CC4

ClinChoice

Address

Fort Washington, PA
USA

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