SAS Programmer/ Statistical Programmer
Cognizant Technology Solutions India Pvt Ltd
Location
Secunderabad | India
Job description
JOB DESCRIPTION
Location: ÂMumbai, Pune, Ahmedabad, Bangalore, Chennai, Hyderabad, Kochi, Gurgaon
Mandate Skills:ÂSDTM, ADAM, TLF on clinical trials phase 1-4`
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.
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