Clinical SAS Programmer

1 month ago

Bengaluru, India 2coms 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 complexbusiness than 1,500 staff delivers technical and domain expertise across multiple platforms and industriesto help enterprise companies drive productivity, efficiency and gain the most out of their technology investments.JOB Description:Graduate/Post-Graduate inStatistics/Mathematics/Computer Science/Life Sciences.

At least 7+ years of experience inStatistical programming and/or design and analysis of Phase I to Phase IVclinical trials in a Contract Research Organization or Pharmaceutical orBiotechnology Company.

·Thorough knowledge of the pharmaceuticalindustry including the understanding of the clinical drug development process andassociated documents and regulations.

·Goodknowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and otherregulatory guidance documents ( USFDA and EMEA)

·Understandingclient’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 statisticalprogramming domain and related processes

·Assists with developing, monitoring, andenforcing productivity and quality standards along with relateddocumentations

·Coordinating with the project management inmeeting the timeline and defining/ capturing the metrics for monitoring andmaintaining the quality and productivity

·Good verbal and written communication skillscoupled with good organizational skills

Technical:

·StrongAnalytical and programming Skills using statistical software SAS or equivalentwith understanding of development and/or execution of SAS macros

·Knowledgeof R will be an added advantage

·Shouldhave worked on generating and validating tables, listings and figures

·Shouldhave worked on Derived datasets/Analysis Datasets/ADaM/SDTM

·Morecomplex review (programs with high risk)

·Programmingand review of outputs for DSUR,PSUR, publications

·Exposureon Exploratory analyses is an added advantage

·Programmingand review of analysis data sets.

·Providetraining and guidance to lower level andnew staff.

·Experiencein submission packages (, SDRG, ADRG, P21 reports)

Compliance:

•Adherence to SOPs and GPP

·Qualityand adherence to timelines.

·Self-motivationand self-learning

·Achievementorientation

·Relationshipbuilding ability

·Inclinationtowards being process driven

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