Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications.
Generate SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files.
Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
Maintain complete and auditable documentation of all programming activities.
Review output across SAS programs to ensure consistency.
Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
Assist Clinical Data Managers with data review via SAS programmed data checks and listings.
Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
Participate in the development and/or maintenance of departmental procedures and standards.
Review CRFs, edit check specifications, and table mock-ups.
Work collaboratively with cross functional groups, study team, and vendors.
May assist in creation of table, figure, or listing mockups under supervision of statisticians.

Requirements

Bachelor’s degree in Statistics, Mathematics, or in a related field; Master’s preferred.
Minimum of 8 to 10 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
Extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
Excellent communication and interpersonal skills to effectively interface with others.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

SASSAS MacrosSAS/STATSAS/GraphSAS/SQLSDTM datasetsADaM datasetsDefine.xmlDefine.pdfstatistical programming

Soft Skills

organizational skillstime managementcommunication skillsinterpersonal skillscoordination

Certifications

Bachelor’s degreeMaster’s degree