Produce statistical analyses and develop SAS/R programs for clinical study datasets, tables, listings, and figures. Program to CDISC SDTM/ADaM standards, annotate CRFs, create FDA electronic submission packages (define.xml, patient profiles), ensure SOP compliance, mentor junior programmers, provide training, represent the department in audits, and collaborate with global study teams to deliver quality results on schedule.
About ClinChoice
ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.
Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.
We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.
Primary Responsibilities
- This role reports to the Associate Manager, Statistical Programming, and above
- Produces statistical analysis using SAS/R according to relevant standard operating procedures.
- Ensuring compliance to SOPs
- Programming analysis dataset without a specifications
- Delivers the assigned tasks and projects within agreed timelines and quality standards
- Developing SAS Programs for the statistical analysis of study data, including analysis of datasets, tables, listings, and figures
- Programming according to CDISC SDTM and ADaM datasets
- Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
- Create an electronic submission package to FDA, e.g., Patient Profile or Subject Narratives, ISO Listings, define.xml, or define.pdf following FDA guidelines.
- Preparing and performing internal training on statistical programming processes and techniques
- Make certain that indication or project documents and specifications are consistent and comply with company/client standards by providing the inputs into study SAP, Protocol, CRF, and outputs
- Provide guidance, mentoring, training for junior team members and help solve issues from cross-functional teams
- Represent ClinChoice/Department during internal and external audits
- Communicating effectively with the internal project team and global team. Collaborate closely with the study/working group.
- Reporting issues to the Project or Study leads or Supervisors in an appropriate time frame
- Responsible for continuous development of own skills according to Individual development plan.
- Actively present in knowledge-sharing meetings, ask questions and share feedback to improve the process or standards of the programming continuously.
- Proactively communicate and collaborate with the global team by understanding the time zone differences.
- Conducts other statistical programming activities as required
- Conduct other administrative and departmental activities as needed
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