Beyond study delivery, you'll have the opportunity to influence the future of programming operations through process improvement initiatives, mentoring, training, and the development of departmental standards and best practices.
Where You'll Work
This is a REMOTE role open to candidates based in Kochi/Trivandrum. You will collaborate with global teams across multiple time zones.
What You'll Do
Lead statistical programming activities across multiple complex clinical studies, ensuring high-quality and timely delivery of datasets, analyses, and submission packages.
Develop, validate, and review CDISC-compliant SDTM and ADaM datasets, as well as tables, figures, and listings (TFLs) to support clinical study reporting and regulatory submissions.
Provide expert guidance on clinical database specifications, data transfer agreements, analysis datasets, TFL shells, and submission documentation.
Serve as a programming project lead, managing priorities, resources, study timelines, and stakeholder communications across internal and external teams.
Drive compliance with global regulatory requirements and industry standards, including CDISC, FDA, PMDA, ICH, GDPR, and applicable quality procedures.
Champion continuous improvement initiatives through the development of programming standards, SAS macros, templates, and operational efficiencies.
Mentor, train, and coach Statistical Programmers, Biostatisticians, Data Managers, and other stakeholders on programming processes, standards, and regulatory expectations.
Support audits, inspections, proposal reviews, budgets, bid defenses, and sponsor meetings as a subject matter expert in statistical programming.
What You'll Bring
Degree-level education or an equivalent qualification, combined with a minimum of 6 years of relevant statistical programming experience.
Advanced SAS programming expertise, including SAS/Macro, Proc Report, ODS, Proc SQL, SAS/STAT, and related programming applications.
Extensive experience creating and reviewing CDISC SDTM and ADaM datasets, TFLs, and electronic submission deliverables.
Demonstrated experience providing technical leadership and programming oversight for complex clinical studies and projects.
Strong understanding of regulatory submission requirements and industry standards, including CDISC, FDA, PMDA, ICH, GDPR, and Good Clinical Practice (GCP).
Proven ability to lead projects, manage competing priorities, and collaborate effectively with sponsors and cross-functional teams.
Excellent analytical, problem-solving, communication, mentoring, and training skills, with exceptional attention to detail.
Proficiency in English.
Discover the Difference
We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.
