Phastar

Principal/Senior - Statistical Programmer

Phastar

full-time

Posted on:

Location Type: Remote

Location: India

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Job Level

Senior

About the role

  • Program and validate datasets and SDTMs, including complex efficacy, labs, etc.
  • Adhere to client SOPs and work on client systems
  • Oversight of Vendor Programming
  • Knowledge of FDA CRT requirements including define.xml and define.pdf
  • Lead team and be responsible for creation of CRT packages
  • Become independent technical expert
  • Program complex non-efficacy outputs/figures
  • Perform Senior Review and Deliver QC of non-statistical output
  • Become involved in developing the standard macro library and take responsibility to implement standard macros within a study
  • Validate and perform User Acceptance Testing (UAT) on standard macros
  • Identify macros requirements, communicate and perform training
  • Create, QC and update complex dataset specifications (including efficacy) for single/multiple studies, ISS/ISEs, etc.

Requirements

  • Educated to BSc or above within Computer Science, Mathematics or a Science related discipline
  • Good awareness of clinical trial issues, design, and implementation
  • In-depth knowledge of SDTM, including but not limited to controlled terminology
  • Experience in ECRT package preparation (aCRF, Define.xml, cSDRG)
  • Strong programming skills
  • Ability to lead projects and work independently
  • Strong SAS programming and clinical trial experience
  • Prior experience in RWD projects is preferred but not essential.
Benefits
  • Be part of a team known for technical expertise, quality, and impact.
  • We value Excellence, Collaboration, Integrity, Innovation, and Passion—and we seek team members who embody these qualities.
  • Phastar is committed to the principles and practices of equal opportunities and to encourage the establishment of a diverse workforce.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SASSDTMECRT package preparationdefine.xmldefine.pdfUser Acceptance Testingmacro library developmentdataset specificationsprogrammingdata validation
Soft Skills
leadershipindependencecommunicationproject managementtraining