Clinical Application Specialist - Statistical Programmer

Collabera; North Chicago (IL); Remote; USD 83,000 - 96,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid parking/public transportation

Paid time off

Job summary

Collabera is seeking an experienced Statistical Programmer to support clinical trial safety and efficacy analyses with hands-on SAS programming and ADaM dataset development. Strong CDISC ADaM/SDTM knowledge and ability to interpret study documentation are essential for producing tables, listings and figures.

The role involves collaboration with statisticians and other programmers to deliver accurate analysis outputs and contribute to regulatory submissions.

Qualifications

• 6 to 8 or more years of SAS programming experience supporting clinical trials.
• Strong hands on experience developing ADaM datasets and specifications.
• Experience interpreting Statistical Analysis Plans and translating requirements into programming deliverables.
• 8 or more years of ADaM and TLF programming experience as specified in the job requirements.
• Experience generating clinical Tables, Listings and Figures for safety and efficacy analyses.

Responsibilities

• Interpret annotated CRFs, SDTM data, SAPs to develop ADaM specifications and datasets.
• Develop and support ADaM programming for clinical trial analyses.
• Create, validate, review ADaM datasets per CDISC standards.
• Generate and review Tables, Listings and Figures supporting safety and efficacy analyses.
• Support clinical trial data analysis and reporting activities.
• Collaborate with statistical programmers and statisticians to deliver outputs.
• Learn and apply internal macros, standards, and processes.

Skills

SAS programming

ADaM datasets

ADaM specifications

CDISC standards

Clinical trial programming

Data analysis

Education

Master's degree in Statistics

Tools

SAS Studio

SAS Enterprise Guide

Job description

Pay Range:

$60 to $70 an hour.

Job Mode:

100% Remote

Duration:

3 Months Contract, with potential extension based on performance and business need.

Job Summary:

We are seeking an experienced Statistical Programmer to support clinical trial safety and efficacy analyses.

The role focuses on hands on SAS programming, ADaM dataset development, and clinical data analysis.

The ideal candidate will have strong knowledge of CDISC standards, including ADaM and SDTM.

This position involves interpreting clinical study documentation and generating clinical Tables, Listings and Figures.

The candidate will collaborate closely with statistical programmers and statisticians to support clinical trial reporting and submission activities.

Key Responsibilities:

• Interpret annotated Case Report Forms, SDTM data, Statistical Analysis Plans, and study programming plans to develop ADaM specifications and datasets.
• Develop and support ADaM programming for clinical trial analyses.
• Create, validate, and review ADaM datasets in accordance with CDISC standards.
• Generate and review clinical Tables, Listings and Figures supporting safety and efficacy analyses.
• Support clinical trial data analysis and reporting activities.
• Collaborate with statistical programmers and statisticians to deliver accurate and high quality programming outputs.
• Learn and apply internal programming macros, standards, and processes.

Required Qualifications:

• 6 to 8 or more years of SAS programming experience supporting clinical trials.
• Strong hands on experience developing ADaM datasets and specifications.
• Experience interpreting Statistical Analysis Plans and translating requirements into programming deliverables.
• 8 or more years of ADaM and TLF programming experience as specified in the job requirements.
• Experience generating clinical Tables, Listings and Figures for safety and efficacy analyses.
• Strong knowledge of CDISC standards, including ADaM and SDTM.
• Clinical trial programming experience in a pharmaceutical or CRO industry environment.
• Strong analytical, communication, and collaboration skills.

Preferred Qualifications:

• Experience in immunology clinical trials.
• Experience in rheumatology, dermatology, gastroenterology, or neuroscience studies.
• Experience with SAS Studio or SAS Enterprise Guide.
• Experience supporting electronic clinical submissions.
• Master's degree in Statistics.
• Experience reviewing and validating clinical TLF outputs.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)