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Principal Statistical Programmer/Analyst Consultant
ClinChoicePrincipal Statistical Programmer Consultant working for ClinChoice supporting a global CRO. Engaging in clinical trial data analysis and project collaboration with clients.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in SAS Programming and CDISC Data Standards within the pharmaceutical industry, with a strong focus on data management, validation, and analysis of clinical trial data. Proven ability to collaborate effectively in cross-functional teams and manage multiple tasks in an FDA-regulated environment.
Highest-signal resume keywords
SAS ProgrammingCDISC Data StandardsClinical Study ReportsFDA-Regulated EnvironmentData Management
ATS Keywords
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Hard Skills
SAS Programming LanguageReport GenerationData Validation ProceduresData ListingsSummary TablesGraphics ProductionData IntegrationStatistical ProgrammingData Transfer CoordinationAd-Hoc Request Execution
Soft Skills
Excellent Verbal CommunicationExcellent Written CommunicationInterpersonal SkillsCross-Functional CollaborationTime Management
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryRare DiseaseNDA SubmissionCRO CoordinationClinical Trial Data AnalysisData Management PlanData ReviewData ValidationProject Deadlines
About the role
Key responsibilities & impact- Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings;
- Produce data listings, summary tables, and graphics for interim and final analyses;
- Integrate data across studies within a project. Test, document, review, and validate all programs according to department guidelines;
- Coordinate data transfer and/or programming standards with CROs and vendors. Validate analysis datasets and TFLs from vendors;
- Collaborate with other Biometrics functions for all activities related to the analysis of clinical trial data;
- Responsible for the execution of ad-hoc requests, manuscripts, posters, and presentations.
Requirements
What you’ll need- Minimum of 10 years of SAS programming in the pharmaceutical or biotechnology industry with a BA/BS in computer science, statistics, math, or MA/MS with 8 years of experience;
- Expertise in SAS programming language, report generation, and standards for programming and validation;
- Therapeutic area- Rare Disease
- Experience with CDISC data standards required.
- Experience as a senior statistical programmer at a pharmaceutical or CRO working in an FDA-regulated environment;
- Experience with Clinical Study Reports and NDA submission;
- Ability to work on multiple tasks simultaneously and meet project deadlines;
- Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
Benefits
Comp & perks- ClinChoice offers a supportive culture
- Professional development opportunities