ClinChoice - Senior Statistical Programmer/Analyst II

• 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