TL;DR

Senior Statistical Programmer/Analyst I (Healthcare): Developing SDTM and ADaM datasets using SAS, creating electronic submission packages for FDA, and developing tables, listings, and graphs for clinical study reports with an accent on data analysis challenges and innovative solutions. Focus on applying AI and machine learning concepts, reinforcing regulatory agency requirements, and mentoring team members.

%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 or sponsor guidelines.
Develop SDTM and ADaM specifications and generate datasets using SAS.
Develop tables, listings, graphs, and patient profiles for Clinical Study Reports, posters, and manuscripts.
Create electronic submission packages for FDA, e.g., define.xml or define.pdf, following FDA guidelines.
Provide guidance, mentoring, and training for team members and help solve issues from cross-functional teams.

Requirements

Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, or related scientific disciplines with at least 3 years of clinical programming experience.
Proven knowledge and training in high-level computing languages such as SAS, C/C++, Java, R, Python, MATLAB, and SQL.
In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
Strong communication and coordination skills.
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
Health Insurance