Clinical SAS Programmer

Responsibilities:

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.

Requirements:

You should have a bachelor's degree in Statistics, Mathematics, or in a related field, master's preferred.

Experience has a minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer is required.

You should have a knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.

You should be able to demonstrate extensive knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.

You should possess excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.

You should also possess excellent communication and interpersonal skills to effectively interface with others.

If you have NDA submission experience that is a plus, but not required.