AbbVie Pharmacyclics Sr. SDTM Programmer in Sunnyvale, California

Sr. SDTM Programmer

Location: Sunnyvale, CA

# of Openings: 1


The Sr. SDTM Programmer position will assume CDISC SDTM data programming responsibilities for multiple studies. Major responsibilities include SAS programming activities to generate and/or validate SDTM datasets by reviewing annotated CRFs, mapping specifications, OpenCDISC issues, as well as by risk-based QC approaches. This role will also work with statisticians and SDTM vendors to ensure data completeness, correctness, and consistency according to Pharmacyclics standard.

As needed, this role may also generate clinical programming deliverables to support data cleaning and monitoring activities, including data listings, edit checks, study metrics, reconciliation reports, dictionary coding files, and coded datasets used for statistical analysis.

  • Programming (75%)

  • Develop and/or validate SDTM datasets for statistical analysis and regulatory submission

  • Develop and verify SAS programs/macros to generate data listings, edit checks, study metrics, and reconciliation reports

  • Develop and verify SAS programs/macros to generate MedDRA/WHODrug dictionary coding files and coded datasets

  • Support ad hoc and urgent programming tasks as assigned by management

  • Communication (10%)

  • Work with statisticians to clarify and document SDTM derivation logic in the mapping specifications

  • Work with other statistical programmers to ensure consistent mapping specifications are applied across studies per Pharmacyclics convention

  • Work with data managers to ensure data issues are communicated and addressed in a timely manner

  • Standards (10%)

  • Monitor CDISC and regulatory guidance regarding SDTM Implementation

  • Perform impact assessment and change control for standard version upgrade

  • Process (5%)

  • Adhere to existing SOPs and work instructions​​

Instructions: Identify Span of Control (direct and indirect headcount). Include name and job level/title for all headcount.

This position does not have any direct reports.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled