The Role
Develop and validate SDTM and ADaM datasets, statistical programming specifications, tables, listings, figures, patient profiles, and FDA submission packages using SAS. Support clinical study reports and integrated safety and efficacy summaries while collaborating with statisticians and cross-functional teams. Lead programming activities, mentor team members, interpret regulatory requirements, resolve programming challenges, and review deliverables for quality and consistency.
Summary Generated by Built In
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, 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.
- Proficient in analyze information and develop innovative solutions to programming and data analysis challenges;
- Support the point of contact (POC) of programming 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.
Skills and Qualifications:
- 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. 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 ICH, Good Clinical Practices, 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.
- Good understanding of clinical drug development process.
- Detail-oriented and ability to learn and adapt to changes.
Skills Required
- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or a related scientific discipline
- At least 4 years of clinical programming experience
- Proficiency with SAS
- Knowledge of high-level programming languages including C/C++, Java, R, Python, MATLAB, and SQL
- Ability to decode programming logic, assemble code, and explain it to team members
- Proficiency applying artificial intelligence and machine learning concepts in real-world settings
- In-depth knowledge of ICH, Good Clinical Practices, clinical research, clinical trial processes, and regulatory terminology
- Understanding of the clinical drug development process
- Strong communication and coordination skills with global teams
- Detail orientation and ability to learn and adapt to changes
- Database programming experience
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.
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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.
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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.
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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.
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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.
