TL;DR

Senior Statistical Programmer/Analyst (Clinical Research): Annotating case report forms (CRF), developing SDTM/ADaM specifications, and generating datasets using SAS in support of clinical study reports. Focus on creating electronic submission packages to the FDA and providing guidance to team members.

Location: Americas, Europe, and Asia-Pacific

Company

%hirify_global% is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

Annotate Case Report Forms (CRF) following FDA/CDISC guidelines.
Develop SDTM/ADaM specifications and generate datasets using SAS.
Develop tables, listings, graphs, and patient profiles for clinical study reports.
Create electronic submission packages to the FDA.
Serve as a programming team lead, providing guidance and training to team members.
Coordinate project deliverables, timelines, and resources with global teams or sponsors.

Requirements

Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, or related field.
5+ years of clinical programming experience.
Proven knowledge in computing languages such as SAS, C/C++, Java, R, Python, MATLAB, and SQL.
In-depth knowledge of ICH, Good Clinical Practices, and related regulatory requirements.
Strong communication and coordination skills; ability to communicate with global teams independently.
Detail-oriented with the ability to learn and adapt to changes.

Culture & Benefits

Flexible Working Hours
Full performance and development process with end-of-year reviews
Team events and end-of-year party
Employee satisfaction survey
Health Insurance

Hiring process

Submit your CV.
If you meet the requirements, you will be invited for a phone interview.

Senior Statistical Programmer/Analyst Iii