Senior Statistical Programmer 2

Worldwide Clinical Trials; Thiruvananthapuram; Remote; INR 2,500,000 - 4,500,000; Full time

Job summary

Worldwide Clinical Trials is hiring a Senior Statistical Programmer 2 for a remote position open to candidates in Kerala, India. You will provide technical leadership across complex studies, develop CDISC SDTM/ADaM datasets, and ensure submission-ready deliverables while adhering to regulatory standards.

Collaborating with Data Management, Biostatistics, and sponsors, you will mentor junior staff, drive process improvements, and help shape programming standards and best practices for efficient

Qualifications

• Degree-level education with at least 6 years of statistical programming experience.
• Advanced SAS programming expertise including SAS/Macro, Proc Report, ODS, Proc SQL, SAS/STAT.
• Extensive CDISC SDTM and ADaM experience with TFLs and submission deliverables.
• Strong regulatory submission knowledge and industry standards (CDISC, FDA, ICH, GDPR, GCP).
• Ability to lead projects, manage priorities, and collaborate with sponsors.
• Excellent analytical, communication, and mentoring skills; detail-oriented.
• Proficient in English.

Responsibilities

• Lead programming activities across complex studies, ensure timely delivery of datasets and submission packages.
• Develop, validate, and review CDISC SDTM/ADaM datasets and TFLs for regulatory submissions.
• Provide guidance on database specs, data transfer, analysis datasets, and submission docs.
• Serve as programming project lead, manage timelines, priorities, and stakeholder communications.
• Drive compliance with global regulatory requirements and industry standards (CDISC, FDA, ICH, GDPR).
• Champion process improvements, SAS macros, templates, and operational efficiencies.
• Mentor and train other programmers, statisticians, and data managers.
• Support audits, sponsor meetings, and budget discussions as subject matter expert.

Skills

SAS Programming

CDISC SDTM/ADaM

Regulatory Submissions

Leadership & Mentoring

English Proficiency

Analytical Thinking

Education

Bachelor's degree

Tools

SAS Macro

SAS/STAT

ODS

Proc SQL

Job description

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

Make an Impact as a Senior Statistical Programmer 2 at Worldwide

Play a key role in delivering high-quality clinical trial data that supports regulatory submissions and advances the development of new therapies. As a Senior Statistical Programmer 2, you will provide technical leadership across complex studies, applying advanced statistical programming expertise to ensure accurate, compliant, and submission-ready deliverables.

In this role, you'll collaborate with cross-functional teams including Data Management, Biostatistics, and sponsors to drive programming strategy, oversee study deliverables, and provide guidance on data standards and regulatory requirements. Your expertise will help shape efficient processes, strengthen quality standards, and support successful study outcomes.

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.