Sr. Stat. Prog. Specialist

Summary of Responsibilities:

• With sufficient experience assume the role of a Lead Statistical Programmer for CP studies only with support from senior programming staff.
• 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 eCRFs and Reviews Guides to support SDTMs and ADaMs.
• With support from senior programming staff develop specifications for SDTMs and ADaM datasets.
• Review SAPs and TFL shells from a programming perspective for studies with support from senior programming staff.
• Respond to QA and client audits with support from senior programming staff.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• Bachelors degree preferably in mathematics statistics computing life science health science or related subjects.
• Experience and/or education plus relevant work experience equating to a Bachelors 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 4 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:
• 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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