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Senior Statistical Programmer, FSP
Clinical Outcomes Solutions. Perform data manipulation, analysis and reporting of clinical trial data, including safety and efficacy, using SAS programming .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in SAS programming for clinical trial data manipulation, analysis, and reporting, with a strong understanding of CDISC SDTM and ADaM standards. Proven ability to generate complex reports and submission documents while collaborating effectively with cross-functional teams.
Highest-signal resume keywords
SAS ProgrammingCDISC SDTM / ADaM StandardsEfficacy AnalysisQC / Validation SkillsAd-Hoc Reporting
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data ManipulationData AnalysisClinical Trial ReportingStatistical AnalysisDataset GenerationSubmission Document CreationECRTs ReviewDefine.xml UtilizationOncology Study SupportImmunology Study Support
Soft Skills
Analytical SkillsTroubleshooting SkillsTeam CollaborationAdaptabilityCommunication Skills
Industry Keywords
Pharmaceutical IndustryBiotech IndustryDrug Development Life CycleClinical Trial DataCross-Functional Teams
About the role
Key responsibilities & impact- Perform data manipulation, analysis and reporting of clinical trial data, including safety and efficacy, using SAS programming
- Generate and validate SDTM and ADaM datasets/analysis files and tables, listings, and figures (TLFs)
- Perform production and QC/validation programming
- Generate complex ad-hoc reports using raw data
- Apply strong understanding and experience of efficacy analysis
- Create and review submission documents and eCRTs
- Communicate with internal cross-functional teams and clients regarding project specifications, status, issues, and inquiries
- Contribute as a team player to achieve results and meet deadlines
- Adapt to changing priorities
Requirements
What you’ll need- Bachelor’s degree in Statistics, Computer Science, Mathematics, etc.
- At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent
- At least 6 years of related experience with a master’s degree or above
- Study lead experience preferred
- Strong SAS data manipulation, analysis and reporting skills
- Solid experience implementing CDISC SDTM / ADaM standards
- Strong QC / validation skills
- Good ad-hoc reporting skills
- Proficiency in efficacy analysis
- Familiarity with the drug development life cycle and clinical trial data manipulation, analysis and reporting
- Submissions experience utilizing define.xml and other submission documents
- Experience supporting oncology or immunology studies is a plus
- Excellent analytical and troubleshooting skills
- Ability to provide quality output and deliverables within challenging timelines
- Ability to work effectively in a globally dispersed team environment with cross-cultural partners
Benefits
Comp & perks- Consistent training, development and support
- Significant professional growth opportunities
- Fully remote work arrangement