Responsibilities include:

• Read and understand the program specifications document.
• Prepare SAS analysis datasets, tables, listings, and figures as per specifications.
• Create programs to create graphs and tables that are required in CSRs, safety reports, efficacy reports, etc. ensuring on-time quality delivery.
• Validate and transform datasets as per client assignment specifications.
• Validate tables, listings, and figures as per client assignment specifications.
• Ability to work on data migration from legacy datasets to standards such as CDISC or any other client-specific standard.
• Coordinate with the client and US team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
• Perform all the above tasks using standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) as applicable
• Hands-on exposure working as a Biostatistician (writing SAP, providing statistical inputs to specs/study docs, reviewing study docs from a stats perspective)

Qualifications and Experience:

• Masters in Sciences,  with a minimum of 5 years of SAS programming experience with clinical trial data.
• General knowledge of regulatory requirements and drug development process.
• Fair knowledge of the Clinical trial domain and good SAS programming skills
• Ability to work independently.