5 ELEMENT INFOMATICS Jobs

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 of remote team