About the job
Joining our Clinical SAS programming team, you’ll be involved in the development of Statistical Analysis Plan, SDTM datasets and TLF shells for Pharma Companies. We are hiring for Team Lead & Team Manager, Sr Manager positions and work locations are Ahmedabad, Mumbai, Pune, Bangalore, Gurgaon & Hyderabad.
Interested candidates can please share your resume to email@example.com or feel free to call me at 8074156082 or 7780116246 for any queries.
Typical Minimum Requirements
· A Graduate/Post-Graduate degree in Statistics/Mathematics/Computer Science/Life Sciences
· A minimum of 7+ years of total experience with a at least 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)
· Good understanding of the statistical programming domain and related processes
· 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.
· Experience in submission packages (Define.xml, SDRG , ADRG, P21 reports)
- · Adherence to SOPs and GPP