Statistical Programmer II

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.,