Senior Statistical Programmer

5 days ago


Bengaluru, Karnataka, India Element Infomatics Pvt. Ltd. Full time

Responsibilities : - Create and maintain CDISC compliant datasets (SDTM, ADaM). - Generate Tables, Listings, and Figures (TLFs) for clinical study reports. - Perform efficacy analyses using R programming. - Develop and utilize standard macros for data manipulation and analysis. - Participate in study handling activities (for senior levels). - Utilize CRT package (trial data domain) for data analysis. - Contribute to Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses. - Work within a Functional Service Provider (FSP) environment. - Troubleshoot and resolve programming issues and errors. - Ensure compliance with regulatory guidelines and company SOPs. - Collaborate with biostatisticians and clinical data managers to support clinical trial activities. - Develop and maintain programming documentation. Requirements : - 6 to 14 years of relevant experience in statistical programming. - Strong knowledge of CDISC standards (SDTM, ADaM). - Extensive experience in generating TLFs. - Proficiency in R programming (minimum 6 months experience). - Experience in efficacy analysis. - Experience with CRT package (trial data domain) preferred. - Experience with ISS and ISE preferred. - Experience working in an FSP environment. - Knowledge of utilizing and debugging standard macros. - Study handling experience preferred (for senior levels) Qualifications : - Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related field. - Proven experience in statistical programming for clinical trials. - Strong understanding of clinical data management principles. - Excellent problem-solving and analytical skills. - Ability to work independently and as part ofa remote team (ref:hirist.tech)



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