• 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