Statistical Programmer

Job Description :

STATISTICAL PROGRAMMER

This essential team member will be responsible for supporting the SAS statistical programming efforts for clinical and non-clinical projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs to meet the project's needs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of programming standards and procedures.

 

SCOPE AND RESPONSIBILITIES

Ability to write SDTM and ADaM specs

Serve as the primary project team representative, delegating work as appropriate

Generate SDTM domains, ADaM datasets, and Define.xml files with proficiency in creating specification files for these domains

Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data.

Review output across programs to ensure consistency

Review, maintain, and approve study documents per standard procedures

Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests

Program, test, and document global utility programs and tools in accordance with standards and validation procedures

Provide technical oversight and leadership in the areas of analysis and reporting

Participate in the development and/or maintenance of departmental procedures and standards

Train and mentor new programmers

 

DESIRED SKILLS & EXPERIENCE

BS degree in Statistics, Mathematics, or Computer Science or in a related field

Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer programming CDISC data structures

Demonstrates 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 work in a team environment.