TL;DR

Senior Statistical Programmer/Analyst II (Clinical Research): Generating SDTM and ADaM datasets using SAS based on Statistical Analysis Plan with an accent on developing Tables, Listings, Graphs, and Patient Profiles in support of the Clinical Study Report, Posters, and Manuscripts. Focus on creating electronic submission packages to FDA and providing guidance, mentoring, and training for 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 Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
Develop SDTM specifications and generate SDTM datasets using SAS.
Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.

Requirements

Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 4+ 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.
Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
Good understanding of clinical drug development process.
Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.

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 - your feedback is important for continuous improvement
Health Insurance