This is an advanced-level Senior Statistical Programmer Analyst position. Key responsibilities and skills may include, but are not limited to: • 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. • Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). • Create electronic submission package to FDA, e.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 crossfunctional teams. • Review draft and final production deliverables for project to ensure quality and consistency. Qualifications • Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology 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. 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.
Job Type: Full-time
Pay: $50.62 - $65.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
Experience level:
Schedule:
Experience:
- Informatica: 1 year (Preferred)
- SQL: 1 year (Preferred)
- Data warehouse: 1 year (Preferred)
Work Location: Remote