Principal Statistical Programmer - SDTM

Premier Research Group; United States; Remote; USD 100,000 - 140,000; Full time

Job summary

A leading company in clinical research seeks a Lead Biostatistical Programmer to join their Centre of Excellence team. The role focuses on SAS programming tasks, ensuring quality and compliance with CDISC specifications. Ideal candidates will have extensive experience in clinical trials and advanced programming skills in SAS.

Qualifications

• 6-8 years of experience in SAS programming within clinical trials.
• Advanced knowledge of SAS macro development and data set architecture.
• Experience with ICH and local regulatory authority regulations preferred.

Responsibilities

• Develop and validate SAS programs for listings, tables, and figures.
• Perform quality control including source code and log reviews.
• Lead communications with the study team and act as Lead Biostatistical Programmer.

Skills

SAS programming

Quality control

CDISC specifications

Data management

Education

BS in statistics, IT, mathematics or closely related field

Tools

SAS Software

Job description

In this role you will be part of our Centre of Excellence team working specifically in SDTM therefore extensive experience and knowledge is required in this area.

Location: Home-based

What you'll be doing:

• Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells.
• Performs quality control (source code review, double-programming and log review) of SAS programs.
• Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications.
• Prepares specifications for CDISC and other analysis data sets.
• Assists Data Management with SAS programming needs.
• Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team.
• Develops and validates general SAS macros.

What we are searching for:

• BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work-related experience to be able to perform this role.
• 6-8 years of experience in SAS programming within the area of clinical trials.
• Prior experience using computerized information systems preferred.
• Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
• Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques.
• Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.