Senior Statistical Programmer - Analytics Element Infomatics (India) Pvt. Ltd.

6.0 - 14.0 years

0 Lacs

karnataka

On-site

You will be responsible for creating and maintaining CDISC compliant datasets (SDTM, ADaM) and generating Tables, Listings, and Figures (TLFs) for clinical study reports. Your role will involve performing efficacy analyses using R programming, developing standard macros for data manipulation, and participating in study handling activities if you are at a senior level. You will utilize the CRT package for data analysis and contribute to Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses. Working within a Functional Service Provider (FSP) environment, you will troubleshoot programming issues, ensure compliance with regulatory guidelines and company SOPs, and collaborate with biostatisticians and clinical data managers to support clinical trial activities. Additionally, you will be responsible for developing and maintaining 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 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 of a remote team.,

Posted 1 week ago

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