The Lead Statistical Programmer will plan, execute, and oversee all programming activities for clinical studies, including resource estimation and budget management. They will develop SAS programs for SDTM and ADaM datasets while mentoring junior staff and ensuring high-quality deliverables.
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 SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviews Guides to support SDTMs and ADaMs.
Develop specifications for SDTMs and ADaM datasets.
Review SAPs and TFL shells from a programming perspective for studies.
Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs.
Present and share knowledge at department meetings.
Respond to QA and client audits, and support qualification audits.
Identify processes within programming that will increase productivity, quality, and efficiency.
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: Speaking: Yes, English required Writing/Reading: Yes, English required
Experience (Minimum Required):
Typically, 3-5 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.
Knowledge of CDISC requirements.
Physical Demands/Work Environment:
Office or home-based environment, as requested by the line manager.
Travel Requirements: Yes.
Local, Domestic, Regional.
% of time: Approximately 5%.
% of the above that requires overnight stay: Approximately up to 100%.
Travel is primarily to where: client meetings and trainings.
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