Statistical Programmer

Overview

Remote
Depends on Experience
Contract - Independent
Contract - W2

Skills

Auditing
CDISC
Clinical Trials
Collaboration
Communication
Conflict Resolution
Data Analysis
Data Visualization
Documentation
FOCUS
Leadership
Macros
Mentorship
Pivotal
Problem Solving
Python
Quality Control
Regulatory Compliance
Reporting
SAS
SDTM
SQL
Statistics
Workflow
R

Job Details

Job Title: Statistical Programmer Location: Remote

Key Responsibilities
Develop, validate, and maintain SAS programs for statistical analysis, regulatory submission, and reporting deliverables.

Create analysis datasets (ADaM) and tables, listings, and figures (TLFs) for clinical trial data analysis.

Collaborate with statisticians and data managers to define specifications for datasets and statistical outputs.

Ensure compliance with CDISC standards, internal SOPs, and regulatory guidelines (FDA, EMA).

Lead programming efforts for pivotal Phase II and III studies with a focus on safety ADaM/TLF production.

Conduct quality control (QC) checks and peer reviews of SAS code and outputs.

Support regulatory submissions, including eCTD packages and responses to agency queries.

Document all programming activities, ensuring traceability and clear audit trails.

Mentor junior programmers and/or lead small programming teams or projects.

Contribute to the development of study protocols, statistical analysis plans (SAPs), and analysis dataset documentation.

Utilize advanced programming techniques or automation tools to optimize workflows.

Required Qualifications
5+ years of hands-on experience in statistical programming for clinical trials, especially in ADaM and TLF production.

Proven leadership in pivotal Phase II/III studies.

Strong expertise in SAS programming (Base, Macro, SQL).

Working knowledge of R or Python is a plus.

Deep understanding of CDISC standards (SDTM, ADaM).

Familiarity with FDA/EMA regulatory submission requirements.

Excellent communication and problem-solving skills.

Experience in oncology, rare diseases, or global trials is highly desirable.

Exposure to automation tools or advanced data visualization techniques is a plus.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.