Senior Statistical Programmer

Fortrea•San Jose, CA

About The Position

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. Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

Requirements

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.
Speaking: Yes, English required
Writing/Reading: Yes, English 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.

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.