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.
