Senior Statistical Programmer

Simulstat Inc.

United States

3 months ago

Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

4 years minimum

Working hours

Regular working hours

Job source

indeed.com

Tech stack

Data Validation SAS (Software) SQL Databases Extensible Markup Language (XML) Information Technology Data Management

Job description

Program and validate SDTM/ADaM datasets supporting a Phase 3 pivotal trial, including longitudinal lab endpoints and averaged-timepoint primary endpoint derivations
Develop, execute, and QC TFLs; review and validate outputs generated by CRO and vendor partners
Perform dataset compliance reviews against CDISC standards across active study phases; maintain Define.XML
Develop data validation programs to support the Data Management team throughout study conduct
Periodically re-run and verify existing code to ensure ongoing program integrity across multiple related studies

Requirements

Do you have experience in XML?, Do you have a Bachelor’s degree?, * Bachelor’s degree or higher in a quantitative discipline (Statistics, Mathematics, Computer Science, or similar)

Four or more years of SAS programming in a pharma or CRO setting across Phase I-IV trials; Phase 3 pivotal trial experience required, rare disease or orphan drug exposure a plus
Proficiency in SDTM, ADaM, and Define.XML; working knowledge of CDISC/CDASH, eCTD, and applicable regulatory guidelines (FDA, ICH, GCP)
Strong SAS skills across ODS, SQL, Macro, Stat, and Graph; expertise with R a plus
Comfortable managing competing priorities across multiple active studies in a fast-moving environment