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.,
You are a highly skilled Senior SAS Programmer sought to support statistical programming activities for clinical trials. Your responsibilities include end-to-end SAS programming for analysis and reporting, ensuring regulatory compliance, data standards, and high-quality deliverables. Your expertise in efficacy analysis, SDTM and ADaM generation, and TLF programming is crucial for this role. You will manipulate, analyze, and report clinical trial data using SAS, generating and validating SDTM and ADaM datasets in adherence to CDISC standards. Additionally, you will create and validate Tables, Listings, and Figures (TLFs) for study reports and regulatory submissions. Your role involves developing complex ad-hoc reports from raw clinical data and applying a deep understanding of efficacy analyses and clinical endpoints. Contribution to the preparation and review of submission documents and eCRTs is expected, as well as production programming and quality control to ensure accuracy and consistency. As a team player, you will commit to quality and meeting project deadlines, remaining adaptable and flexible in a fast-paced clinical environment. Qualifications required include a Bachelors or Masters degree in Life Sciences, Statistics, Computer Science, or a related field, along with 6+ years of hands-on experience in clinical trial programming using SAS. Proficiency in CDISC standards, Base SAS, SAS Macros, SAS/STAT, and SAS/GRAPH is essential. Experience in generating datasets and outputs for regulatory submissions and familiarity with eCTD standards are preferred. Strong attention to detail and analytical problem-solving skills are necessary for this role. Join a collaborative team environment where your expertise in clinical data programming directly contributes to advancing global healthcare. Precision, integrity, and innovation are valued in every project undertaken.,
Job Title: Senior SAS Programmer Location : Hybrid (Hyderabad/Mumbai/Pune/Bangalore) Employment Type : Full-Time Experience : 7+ Years Job Summary: We are seeking a highly skilled Senior SAS Programmer to support the statistical programming activities for clinical trials. This role involves end-to-end SAS programming for analysis and reporting, with a focus on regulatory compliance, data standards, and high-quality deliverables. The ideal candidate should have strong experience in efficacy analysis, SDTM and ADaM generation, and TLF programming. Key Responsibilities: Perform data manipulation, analysis, and reporting of clinical trial data, including both safety and efficacy datasets (ISS/ISE), using SAS . Generate and validate SDTM and ADaM datasets in accordance with CDISC standards. Create and validate Tables, Listings, and Figures (TLFs) for study reports and regulatory submissions. Develop complex ad-hoc reports from raw clinical data. Apply a strong understanding of efficacy analyses and clinical endpoints. Contribute to the preparation and review of submission documents and electronic Case Report Tabulations (eCRTs) . Perform production programming and quality control (QC/validation) to ensure accuracy and consistency. Act as a team player , demonstrating commitment to quality and meeting project deadlines. Stay adaptable and flexible to shifting priorities in a fast-paced clinical environment. Required Qualifications: Bachelor’s or Master’s degree in Life Sciences, Statistics, Computer Science , or a related field. 7+ years of hands-on experience in clinical trial programming using SAS . Proficient in CDISC standards (SDTM, ADaM), including mapping and validation. Strong working knowledge of Base SAS, SAS Macros, SAS/STAT, and SAS/GRAPH . Experience in generating datasets and outputs for regulatory submissions (including ISS/ISE). Familiarity with eCTD standards , including Define.xml and dataset documentation. Excellent attention to detail and strong analytical problem-solving skills. Why Join Us? Join a collaborative team environment where your expertise in clinical data programming directly contributes to advancing global healthcare. We value precision, integrity, and innovation in every project we undertake.