Hiring for Leading companies / Sas Programming

Job Description:

JOB DESCRIPTION – SAS Programmer
Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.
A minimum of 6+ 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, ICH-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 reviewing analysis data sets.
 Provide training and guidance to lower level and new staff.
 Experience in submission packages (Define.xml, SDRG, ADRG, P21 reports)
Compliance:
• Adherence to SOPs and GPP.
 Quality and adherence to timelines.
 Self-motivation and self-learning.
 Achievement orientation.
 Relationship building ability.
 Inclination towards being process driven.