Senior Statistical Programmer

Clinical Outcomes Solutions

. Generate and validate statistical programming deliverables, including SDTM, ADaM, and TFLs .

Posted 10/22/2026full-timeUnited StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in SAS programming for clinical trial data analysis and reporting, with a strong focus on SDTM, ADaM, and efficacy analysis. Proven ability to collaborate with cross-functional teams and deliver high-quality outputs within tight deadlines.

Highest-signal resume keywords

SAS ProgrammingClinical Trial Data AnalysisEfficacy AnalysisCDISC SDTM/ADaM StandardsQC/Validation Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingData ManipulationComplex Programming AlgorithmsAd-Hoc ReportingPharmacokinetic Data AnalysisSubmission Document CreationEfficacy and Safety AnalysisGlobal Programming Standards DevelopmentEarly Development StudiesDefine.XML Knowledge

Soft Skills

Analytical SkillsTroubleshooting SkillsTeam CollaborationAdaptabilityCommunication Skills

Tools & Technologies

SASRSPlusNonMem

Industry Keywords

Pharmaceutical IndustryBiotech IndustryClinical TrialsDrug Development Life CycleOncology Studies

About the role

Key responsibilities & impact

Generate and validate statistical programming deliverables, including SDTM, ADaM, and TFLs
Perform safety and efficacy data manipulation, analysis, and reporting for clinical trials using SAS
Perform production and QC/validation programming
Generate complex ad-hoc reports using raw data
Apply expertise in efficacy analysis
Create and review submission documents and eCRTs
Communicate with internal cross-functional teams and clients regarding project specifications, status, issues, and inquiries
Perform lead duties when called upon
Collaborate as a team player to achieve results and meet deadlines
Adapt to changing priorities
Support or lead Early- or Late-stage clinical trials for a global pharmaceutical client
Work on Early Development Statistics and PK/PD Modeling and Simulation across therapeutic areas

Requirements

What you’ll need

Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field
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
Experience/expertise working on Early Development studies
Programming expertise with clinical endpoint data, including efficacy and safety, and pharmacokinetic data
Experience developing and validating global programming standards for ADaM datasets
Experience developing and validating global programming standards for efficacy analysis, safety analysis, and reporting
Ability to design and develop complex programming algorithms
Strong SAS data manipulation, analysis, and reporting skills
Solid experience implementing current CDISC SDTM/ADaM standards
Knowledge of CDISC SDTM, Define.XML, SDRG, and aCRF submission 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
Submission experience using define.xml and other submission documents
Excellent analytical and troubleshooting skills
Ability to deliver quality outputs and deliverables within challenging timelines
Ability to work effectively in a globally dispersed team environment with cross-cultural partners
R, SPlus, and NonMem experience preferred
Oncology studies experience would be a plus
Hybrid office-based work in Pennsylvania preferred or New Jersey

Benefits

Comp & perks

Consistent training, development and support
Significant professional growth
Professional development opportunities implied through staff training and development