Job Title: Statistical Programmer II Experience: 4+ Years Location: Hyderabad (Onsite) Employment Type: Full-Time About Princeps Technologies: Princeps Technologies is a data-driven organization delivering advanced analytics and technology solutions to the pharmaceutical and biotechnology industries. We are committed to innovation, quality, and client success. Role Overview: We are seeking a skilled Statistical Programmer II to join our team onsite in Hyderabad. The ideal candidate will have hands-on experience with SDTM and ADaM programming, TLF generation, and regulatory submission support within the clinical trial space. Key Responsibilities: Develop and validate SDTM datasets based on CDISC standards. Create ADaM datasets in accordance with current ADaM implementation guidelines. Program Tables, Listings, and Figures (TLFs) as per sponsor requirements. Generate subject narratives using approved templates. Produce clinical registry files (e.g., ClinicalTrials.gov, EudraCT) and BIMO reports . Perform quality control (QC) and validation of all programming deliverables. Prepare and maintain specification documentation for datasets and outputs. Develop electronic submission packages that comply with global regulatory standards (FDA, EMA, etc.). Support data integration across studies for submission and cross-study analysis. You Are: A SAS programmer with 4+ years of experience in clinical trial data analysis. Proficient in SAS Base and Macro programming , especially for SDTM, ADaM, and TLFs. Familiar with clinical domains such as safety , efficacy , and PK/PD . Knowledgeable of CDISC standards (ADaM, SDTM, Controlled Terminologies). Experienced in metadata programming and following sponsor-defined analysis standards. Exposure to Therapeutic Area User Guides (TAUGs) is a plus. R programming experience is an added advantage. Strong in documentation, QC, and regulatory compliance. Preferred Qualifications: Bachelor's or Master’s degree in Statistics, Life Sciences, Computer Science , or related fields. Experience in preparing submission-ready data and documentation. Working knowledge of regulatory expectations from agencies like FDA and EMA. Effective communication skills and a collaborative mindset. Why Join Princeps Technologies? Join a talented and mission-focused team. Contribute to global clinical research and regulatory innovation. Enjoy a supportive work environment with onsite collaboration in Hyderabad. Competitive compensation and professional development opportunities .

The Statistical Programmer II position at Princeps Technologies in Hyderabad is a key role within our organization. As a data-driven company specializing in advanced analytics and technology solutions for the pharmaceutical and biotechnology sectors, we are dedicated to innovation, quality, and client success. As a Statistical Programmer II, you will be responsible for developing and validating SDTM datasets according to CDISC standards, creating ADaM datasets following current guidelines, and programming Tables, Listings, and Figures (TLFs) as per sponsor requirements. Your role will also involve generating subject narratives, producing clinical registry files, performing quality control on programming deliverables, and preparing electronic submission packages that adhere to global regulatory standards. The ideal candidate for this position is a SAS programmer with over 4 years of experience in clinical trial data analysis. You should be proficient in SAS Base and Macro programming, particularly for SDTM, ADaM, and TLFs, and have knowledge of clinical domains such as safety, efficacy, and PK/PD. Familiarity with CDISC standards, metadata programming, and sponsor-defined analysis standards is essential, while experience with Therapeutic Area User Guides (TAUGs) and R programming would be advantageous. To be successful in this role, you should possess strong documentation, quality control, and regulatory compliance skills. A Bachelor's or Masters degree in Statistics, Life Sciences, Computer Science, or related fields is preferred, along with experience in preparing submission-ready data and documentation. Effective communication and collaboration skills are valued, as is an understanding of regulatory expectations from agencies like the FDA and EMA. Joining Princeps Technologies means becoming part of a talented and mission-focused team dedicated to global clinical research and regulatory innovation. You will have the opportunity to work in a supportive environment with onsite collaboration in Hyderabad, along with competitive compensation and professional development prospects.,