Job Description
JOB DESCRIPTION OF Analyst SAS Programmer
Graduate / Post-Graduate in Statistics / Mathematics / Computer Science / Life Sciences.
A minimum of 4 years of total experience with a at least 2 years of experience in Statistical programming
and / or design and analysis of Phase I to Phase IV clinical trials in a Contract Research Organization or
Pharmaceutical or Biotechnology company
Thorough knowledge of the pharmaceutical industry including understanding of clinical drug
development process and associated documents and regulations.
Good knowledge of GCP, Good Programming Practices, ICH-E3, I CH-E9 and other regulatory guidance
documents (e.g. USFDA and EMEA)
Understanding client’s requirement and providing all the required statistical inputs on , SAP, Mock
Shells, Tables, Listings, Figures or any other statistical programming deliveries
Good understanding of the statistical programming domain and related processes
Assists with developing, monitoring, and enforcing productivity and quality standards along with
related documentations
Coordinating with the project management in meeting the timeline and defining / capturing the
metrics for monitoring and maintaining the quality and productivity
Good verbal and written communication skills coupled with good organizational skills
Technical :
Strong Analytical and programming Skills using statistical software SAS or equivalent with
understanding of development and / or execution of SAS macros
Knowledge of R will be an added advantage
Should have worked on generating and validating tables, listings and figures
Should have worked on Derived datasets / Analysis Datasets / ADaM / SDTM
More complex review (programs with high risk)
Programming and review of outputs for DSUR, PSUR, publications
Exposure on Exploratory analyses is an added advantage
Programming and review of analysis data sets.
Provide training and guidance to lower level and new staff .
Experience in submission packages (Define.xml, SDRG, ADRG, P21 reports)
Compliance :
Q uality and adherence to timelines.
Self-motivation and self-learning
Achievement orientation
Relationship building ability
Inclination towards being process driven
CLINICAL SAS
