The Role
Lead clinical programming for FDA submissions: annotate CRFs, develop SDTM/ADaM datasets and specifications, produce TLFs and patient profiles, create define.xml submission packages, mentor and lead programming teams, coordinate with statisticians and global sponsors, and ensure regulatory compliance (ICH/GCP).
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 packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision.
- Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges;
- Serve as 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 initiatives.
- 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.
- Work with global team or sponsors to coordinate project deliverables, timelines and resources.
Skills and Responsibilities:
- Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+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.
- Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
- Expert level in applying concept in Artificial Intelligence and Machine Learning in 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 independently.
- In-depth 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, Engineering, Biotechnology or related
- 5+ years of clinical programming experience
- Proven knowledge and training in SAS, C/C++, Java, R, Python, MATLAB, and SQL
- Experience developing SDTM and ADaM specifications and generating SDTM/ADaM datasets using SAS
- Experience creating regulatory electronic submission packages (define.xml/define.pdf) following FDA/CDISC guidelines
- In-depth knowledge of ICH, Good Clinical Practices, clinical research and clinical trial processes
- Expert-level ability to analyze programming logic, develop solutions, and explain code to team members
- Expert-level application of Artificial Intelligence and Machine Learning concepts in real-world settings
- Strong communication, coordination, mentoring and leadership skills to work with global teams
- 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.
