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

Apply

Statistical Programmer Saarthee

6.0 - 10.0 years

0 Lacs

karnataka

On-site

We are seeking a skilled Statistical Programmer with a strong background in R Programming to become a valuable addition to our expanding team. This remote position is ideal for individuals who are enthusiastic about clinical data analysis and programming, particularly those with a deep understanding of CDISC standards. As a Statistical Programmer, your main responsibilities will include developing, validating, and managing SDTM, ADaM datasets, and TLFs in compliance with CDISC guidelines. You will be conducting efficacy analyses using R programming, working autonomously on studies, and providing support for clinical trial submissions. Collaboration with various teams in an FSP environment will be crucial, along with efficient debugging and utilization of standard macros. If you have experience with integrated summaries (ISS/ISE), it is considered a plus. The ideal candidate should possess 6 to 8 years of relevant experience in statistical programming, with a minimum of 3 years of hands-on experience in R programming. A strong working knowledge of CDISC standards such as SDTM, ADaM, and TLF is essential, along with exposure to efficacy analysis. Senior-level profiles should have experience in handling studies at the study level. Preferred skills for this role include familiarity with the CRT package (Trial Data Domain), previous involvement in ISS and ISE, experience in an FSP environment, and proficiency in standard macro debugging and utilization. In return, we offer a bootstrapped and financially stable environment with an above-industry renumeration package. Additional compensation is tied to Renewal and Pilot Project Execution, along with lucrative business development incentives. Our organization provides opportunities for firm building and holistic professional development, emphasizing empathy, excellence, and results. We believe in mentoring and nurturing our team members, with a continuous focus on learning and growth.,

Posted 1 month ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.