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, 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
· 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)
• 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