The Role
The Statistical Programmer/Analyst III analyzes data, develops SAS programs following CDISC standards, creates datasets, and supports regulatory submissions. Responsibilities include data analysis, programming, and communication with statisticians.
Summary Generated by Built In
Responsibilities:
- Analyze data and report statistical results.
- Develop SDTM specifications for programming datasets following CDISC standard.
- Independently develop SAS programs to create SDTM datasets.
- Develop ADaM analysis data specifications for programming following CDISC standard with minimum supervision.
- Independently develop SAS programs to create ADaM datasets for Analysis and Reporting based on Statistical Analysis Plan.
- Develop, debug, and maintain SAS programs and macros to create Tables, Listings and Graphs for Clinical Study Report following CDISC, industry guidelines and Statistical Analysis Plan.
- Independently implement SAS programs to generate Define-XML package for FDA submission.
- Develop SAS programmable edit checks to assist data monitoring, document and report data issue to Data Management.
- Implement statistical data analysis and communicate with statisticians for statistical input.
- Support regulatory electronic submissions to Food and Drug Administration (FDA) and other worldwide regulatory authorities.
- Perform other programming tasks as needed per management requests.
Skills and Qualifications:
- Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 2+ years of statistical programming experience required.
- 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.
- Ability to translate statistical analysis plan into SAS programming language, to update and fix existing programs.
- Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Good understanding of clinical drug development process.
- Team player, strong communication skills and coordination skills.
- Detail oriented and ability to learn and adapt to changes.
- Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
Skills Required
- Bachelor's/Master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines
- 2+ years of statistical programming experience
- Proven knowledge of SAS and high level computing languages
- Ability to translate statistical analysis plan into SAS programming
ClinChoice Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.
-
Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
-
Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
-
Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.
ClinChoice Insights
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
