Katalyst CRO
Develop and maintain SAS programs to import, clean, and validate clinical trial data. Use R for data manipulation, analysis, and visualization. Perform statistical analyses in accordance with study protocols and analysis plans. Generate tables, listings, and figures (TLFs) using SAS and R. Create and QC statistical outputs and clinical study reports for regulatory submissions. Document programming activities and ensure compliance with Standard Operating Procedures (SOPs). Work closely with biostatisticians, data managers, and clinical researchers. Provide programming support for ad-hoc analysis requests and exploratory data analyses. Perform rigorous quality checks on all deliverables. Maintain annotated datasets and ensure traceability of data processing.
Responsibilities
Develop and maintain SAS programs to import, clean, and validate clinical trial data.
Use R for data manipulation, analysis, and visualization.
Perform statistical analyses in accordance with study protocols and analysis plans.
Generate tables, listings, and figures (TLFs) using SAS and R.
Create and QC statistical outputs and clinical study reports for regulatory submissions.
Document programming activities and ensure compliance with Standard Operating Procedures (SOPs).
Work closely with biostatisticians, data managers, and clinical researchers.
Provide programming support for ad-hoc analysis requests and exploratory data analyses.
Perform rigorous quality checks on all deliverables.
Maintain annotated datasets and ensure traceability of data processing.
Requirements
Bachelor's or master's degree in Statistics, Computer Science, Biostatistics, or a related field.
Minimum of 3 years of clinical SAS programming experience, with a strong background in R.
Proficiency in SAS and R, including data step programming, PROC SQL, and R packages for data analysis.
Experience with CDISC standards (SDTM, ADaM).
Knowledge of clinical trial processes and regulatory requirements (e.g., FDA, EMA).
Strong analytical and problem-solving skills.
Excellent communication skills, both written and verbal.
Seniority level : Associate
Employment type : Contract
Job function : Information Technology
Industries : Pharmaceutical Manufacturing
#J-18808-Ljbffr
#J-18808-Ljbffr