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Statistical Programmer II – Sponsor Dedicated
FortreaStatistical Programmer II leading SAS programming for complex clinical trials at Fortrea. Overseeing programming activities, developing specifications and responding to audits with senior support.
ATS Keywords
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Hard Skills
SAS programmingSDTM datasetsADaM datasetsTFLsQC of SDTMQC of ADaMsQC of TFLsDefine XMLAnalysis Results Metadataannotated eCRFs
Soft Skills
leadershipcommunicationorganizationalresource estimationbudget managementtimelines managementquality maximizationinterdepartmental interactionclient interactionproblem-solving
Certifications & Qualifications
Bachelor's degree
Industry Keywords
CROPharmaceutical industryCDISC requirementsstatistical programmingclinical programmingQA auditsclient auditsprogramming specificationsSAPsTFL shells
About the role
Key responsibilities & impact- 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.
- 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.
- Develop specifications for SDTMs and ADaM datasets with support from senior programming staff.
- 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.
Requirements
What you’ll need- Minimum Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.
- Typically, 1 - 2 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.
- Business fluency in English – both spoken and written – is a must.
Benefits
Comp & perks- Health insurance
- Flexible work arrangements
- Professional development opportunities