2COMS invites applications from eligible candidates for the post of Clinical SAS programmer for its Chennai location.
About 2COMS
2COMS Consulting focuses on the #HumanSideOfThings – helping organizations become sustainable leaders by connecting them to the right talent.
Qualification & Experience
- 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
Salary
15,00000-18,00000
Job Description
- 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 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)
Job Location
Chennai
