Principal Statistical Programmer

3 days ago

Bengaluru, Karnataka, India Fortrea Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Summary of Responsibilities:

  • Perform the role of the Lead Statistical Programmer.
  • Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
  • Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
  • Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs.
  • Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Fortrea and Client standards.
  • Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective.
  • Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes.
  • Present and share knowledge at department meetings.
  • Respond to QA and client audits and support qualification audits.
  • Contribute to proposal activities and participate in bid defenses meetings in order to win new business.
  • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming.
  • And all other duties as needed or assigned.

Qualifications (Minimum Required):

  • Bachelor's degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.
  • Experience and/or education plus relevant work experience, equating to a Bachelor's degree.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Language Skills Required: o Speaking: Yes, English required o Writing/Reading: Yes, English required

Experience (Minimum Required):

  • Typically, 6 years of SAS programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
  • Experience as lead statistical programmer on complex studies in clinical research.
  • Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g., Biostatistics and Clinical Data Management.
  • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including , Reviewer's Guide and submission standards.

Physical Demands/Work Environment:

  • Office or home-based environment, as requested by the line manager.
  • Travel Requirements: Yes.
  • Local, Domestic, Regional, Global.
  • % of time dedicated to travel: 5%.
  • % of the above that requires overnight stay: Approximately up to 100%.
  • Travel is primarily to where: client meetings and trainings.

Learn more about our EEO & Accommodations request here.

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