About the Role

Cytel is actively hiring experienced Senior and Principal Statistical Programmers with 5+ years of expertise to join our remote team across India and Europe. This 100% remote position offers an excellent opportunity for seasoned statistical programming professionals to work on complex clinical trial projects while enjoying complete location flexibility. You'll be responsible for developing, validating, and maintaining SDTM datasets following CDISC standards and ensuring compliance with regulatory requirements, creating ADaM analysis datasets that support statistical analysis and reporting for clinical trials. Your role will involve programming TLFs (Tables, Listings, and Figures) for Clinical Study Reports, regulatory submissions, and data monitoring activities, working across multiple trial phases (Phase I, II, III, IV) and diverse therapeutic areas to deliver high-quality programming deliverables. You'll create and maintain define.xml documentation for study metadata and data specifications, support regulatory submissions to FDA, EMA, and other health authorities with compliant SDTM and ADaM datasets. You'll collaborate with biostatisticians, clinical data managers, and medical writers to ensure accurate data representation and analysis, perform quality control reviews of programming outputs, and mentor junior programmers on CDISC standards and best practices. The ideal candidate possesses deep technical expertise in SAS programming, comprehensive understanding of CDISC standards, and proven experience delivering regulatory-compliant datasets for successful submissions across various therapeutic areas and trial complexities.

What We're Looking For

We need statistical programming professionals with a minimum of 5+ years of hands-on experience in SDTM, ADaM, and TLF programming for clinical trials. You must have strong expertise in SAS programming including Base SAS, SAS Macros, and SAS/STAT for efficient data manipulation and analysis. Deep understanding of CDISC standards (SDTM, ADaM, CDASH) and implementation guidelines is essential, along with proven experience working across multiple trial phases and therapeutic areas such as oncology, cardiovascular, neurology, or infectious diseases. The ideal candidate has solid knowledge of define.xml creation using tools like Pinnacle 21 or similar software, along with experience in regulatory submissions and understanding of FDA, EMA, and ICH guidelines. You should have strong attention to detail in data validation, quality control processes, and ensuring accuracy in programming deliverables. Experience with clinical trial protocols, statistical analysis plans (SAPs), and annotated CRFs is highly valued. Excellent problem-solving abilities, analytical thinking, and the capacity to work independently on complex programming tasks are crucial. Strong communication skills to collaborate effectively with cross-functional teams including biostatisticians, clinical operations, and regulatory affairs are essential. Self-motivation, ability to manage multiple projects simultaneously, and commitment to meeting tight timelines in a remote work environment are qualities we're seeking. Advanced degrees in Statistics, Mathematics, Computer Science, or Life Sciences, along with certifications in SAS or CDISC standards, will be considered advantageous.

How to Apply

Ready to take on your next big opportunity as a Senior or Principal Statistical Programmer with Cytel? We're scheduling 30-minute video screening calls with qualified candidates. Send your updated resume to adish.jindal@cytel.com with the subject line "Statistical Programmer Application - [Your Name]". Please highlight your 5+ years of experience in SDTM, ADaM, and TLF programming, including specific therapeutic areas and trial phases you've worked on. Mention your experience with define.xml creation, regulatory submissions, and any notable projects or achievements in clinical trial programming. Include details about your SAS programming expertise and familiarity with CDISC standards. Indicate your preferred location (India or Europe) and availability for a 30-minute video screening call.

About Company

We advance the future of human health through the power of data science. At Cytel, our mission is to unlock the full potential of data to help life science leaders accelerate drug development and improve patient outcomes. Founded in 1987 by Harvard and MIT scientists Cyrus Mehta and Nitin Patel, Cytel was born from a shared vision to simplify and transform clinical research through advanced analytics. Today, we unite global experts in clinical development, statistical design, real-world evidence, regulatory strategy, and commercialization. As a pioneering scientific community, we deliver innovative, data-driven solutions that shorten timelines, increase success rates, and ultimately change patients’ lives for the better.