Senior Statistical Programmer/Analyst II

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 aboveProduces statistical analysis using SAS/R according to relevant standard operating procedures.Ensuring compliance to SOPsProgramming analysis dataset without a specificationsDelivers the assigned tasks and projects within agreed timelines and quality standardsDeveloping SAS Programs for the statistical analysis of study data, including analysis of datasets, tables, listings, and figuresProgramming according to CDISC SDTM and ADaM datasetsAnnotate 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 techniquesMake 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 outputsProvide guidance, mentoring, training for junior team members and help solve issues from cross-functional teamsRepresent ClinChoice/Department during internal and external auditsCommunicating 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 frameResponsible 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 requiredConduct other administrative and departmental activities as needed .