Principal Statistical Programmer

2 weeks ago

Mumbai India Fortrea Full time

Job Description 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 define.xml, 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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