Summary of JobResponsibilities :
Working under the direction of Team Lead / Project Manager, the senior statistical programmer conducts programming activities for a trial, early phase project, indication, or publication activities.
Lead at least one study team in terms of providing technical and domain related guidance.
May require to lead and manage a team of 2-4 members
Ability to work on data migration from legacy datasets to standards such as CDISC or any other client specific standard.
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.
Co-ordinate with the client and US-team for clarity of specifications, data issues, outliers, reviews, schedules, etc.
Contribute in the organization’s recruitment process by identifying need and required skill set of resources and conducting interviews to hire appropriate resources.
Perform all the above tasks using standard operating procedures (SOPs) as defined in Quality Management System or the respective client(s) as applicable
Qualifications and Experience :
B.Sc. or M.Sc. degree in Computer Science, Statistics, or related health science field with a minimum of 5 - 10 years of SAS programming experience with clinical trial data.
Well conversant with regulatory requirements and drug development process.
Good understanding of Clinical trial domain and good SAS programming skills
Ability to work independently