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Clinical SAS Programmer

3 months ago

Bengaluru, Karnataka, India timesjobs Full time

Location:
Mumbai, Chennai, Bangalore, Hyderabad, Ahemedabad,Delhi NCR

About the Client:

we have retained with CMMI level 4 client with the position of Banking operations for the level of SPE.


Client is a global IT solutions company specializing in delivering simple and scalable solutions to address complex
business problems.
More than 1,500 staff delivers technical and domain expertise across multiple platforms and industries
to help enterprise companies drive productivity, efficiency and gain the most out of their technology investments.

JOB Description:
Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.

At least 7 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 the understanding of the 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 clients 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 , 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