We are looking for a dynamic person to join our in-house team as a Principal Statistical Programmer on a permanent basis. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.
Main Job Tasks and Responsibilities:
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 and Manuscripts.
Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
Create electronic submission package to FDA, g., define.xml or define.pdf following FDA guidelines with minimum supervision.
Analyze information and develop innovative solutions to programming and data analysis challenges.
Actively communicate with statisticians for statistical input and analysis interpretation.
Follow and reinforce regulatory agency requirements during daily job.
Serve as a programming team lead and contribute to department initiative.
Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
Review draft and final production deliverables for project to ensure quality and consistency.
Education, Experience and Skills:
masters / Bachelors degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
8-13 years of experience in Statistical Programming in Clinical domain.
Proven knowledge and training in high level computing languages such as SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
In-depth knowledge of Good Clinical Practice, Clinical Research, Clinical trial process and related regulatory requirements and terminology.
Good understanding of clinical drug development process.
Strong communication skills and coordination skills. Ability to communicate with global teams with supervision.
Detail-oriented and ability to learn and adapt to changes.
Proficient in Microsoft Office Suite, eg, Word, Excel, PowerPoint.
