Statistical Programmer II

Role Overview: As a Statistical Programmer II at Princeps Technologies in Hyderabad, you play a crucial role in the organization's data-driven approach to advanced analytics and technology solutions for the pharmaceutical and biotechnology industries. Your focus will be on developing and validating SDTM datasets, creating ADaM datasets, and programming Tables, Listings, and Figures (TLFs) to meet sponsor requirements. Additionally, you will generate subject narratives, produce clinical registry files, perform quality control on programming deliverables, and prepare electronic submission packages in compliance with global regulatory standards. Key Responsibilities: - Develop and validate SDTM datasets according to CDISC standards - Create ADaM datasets following current guidelines - Program Tables, Listings, and Figures (TLFs) as per sponsor requirements - Generate subject narratives and produce clinical registry files - Perform quality control on programming deliverables - Prepare electronic submission packages adhering to global regulatory standards Qualifications Required: - Over 4 years of experience in clinical trial data analysis as a SAS programmer - Proficiency in SAS Base and Macro programming for SDTM, ADaM, and TLFs - Knowledge of clinical domains such as safety, efficacy, and PK/PD - Familiarity with CDISC standards, metadata programming, and sponsor-defined analysis standards - Experience with Therapeutic Area User Guides (TAUGs) and R programming would be advantageous - Bachelor's or Masters degree in Statistics, Life Sciences, Computer Science, or related fields preferred - Experience in preparing submission-ready data and documentation - Strong documentation, quality control, and regulatory compliance skills - Effective communication and collaboration skills - Understanding of regulatory expectations from agencies like the FDA and EMA (Note: No additional details of the company were mentioned in the provided Job Description),