Clinical Statistical Programmer (Hyderabad)

Location: Pan India (Onsite) Experience: 512 Years We are hiring for a leading global organization and seeking experienced Statistical Programmers with strong expertise in clinical trial data analysis, programming, and regulatory submissions. Key Responsibilities - Develop, validate, and maintain statistical programming deliverables for clinical studies. - Create and validate SDTM and ADaM datasets in compliance with CDISC standards. - Generate and validate Tables, Listings, and Figures (TLFs) for clinical study reports. - Prepare and support submission deliverables including Define.Xml, Reviewer Guides, and related documentation. - Develop and maintain SAS programs, macros, and validation processes. - Utilize R programming for statistical analysis, data visualization, and reporting. - Support regulatory submissions to global health authorities including FDA and EMA. - Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams. - Ensure adherence to industry standards, SOPs, and regulatory requirements. Required Skills & Qualifications - 512 years of experience in Statistical Programming within the Pharmaceutical, Biotechnology, or CRO industry. - Strong hands-on experience with SAS Programming and R Programming. - In-depth knowledge of CDISC standards (SDTM & ADaM). - Experience in developing and validating TLFs, Define.Xml, and Reviewer Guides. - Good understanding of clinical trial processes and regulatory submission requirements. - Experience supporting FDA and EMA submissions. - Strong analytical, problem-solving, and communication skills. Preferred Experience Candidates with experience in any of the following therapeutic areas will be preferred: - Oncology - Immunology - Neuroscience Why Join - Opportunity to work on global clinical development programs. - Exposure to complex clinical studies and regulatory submissions. - Collaborative and high-performing work environment. - Growth opportunities within a leading life sciences organization. Interested candidates may share their updated CV at: Location: Pan India (Onsite) Experience: 512 Years We are hiring for a leading global organization and seeking experienced Statistical Programmers with strong expertise in clinical trial data analysis, programming, and regulatory submissions. Key Responsibilities - Develop, validate, and maintain statistical programming deliverables for clinical studies. - Create and validate SDTM and ADaM datasets in compliance with CDISC standards. - Generate and validate Tables, Listings, and Figures (TLFs) for clinical study reports. - Prepare and support submission deliverables including Define.Xml, Reviewer Guides, and related documentation. - Develop and maintain SAS programs, macros, and validation processes. - Utilize R programming for statistical analysis, data visualization, and reporting. - Support regulatory submissions to global health authorities including FDA and EMA. - Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams. - Ensure adherence to industry standards, SOPs, and regulatory requirements. Required Skills & Qualifications - 512 years of experience in Statistical Programming within the Pharmaceutical, Biotechnology, or CRO industry. - Strong hands-on experience with SAS Programming and R Programming. - In-depth knowledge of CDISC standards (SDTM & ADaM). - Experience in developing and validating TLFs, Define.Xml, and Reviewer Guides. - Good understanding of clinical trial processes and regulatory submission requirements. - Experience supporting FDA and EMA submissions. - Strong analytical, problem-solving, and communication skills. Preferred Experience Candidates with experience in any of the following therapeutic areas will be preferred: - Oncology - Immunology - Neuroscience Why Join - Opportunity to work on global clinical development programs. - Exposure to complex clinical studies and regulatory submissions. - Collaborative and high-performing work environment. - Growth opportunities within a leading life sciences organization. Interested candidates may share their updated CV at: