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Lead SAS Programmer

2 months ago

india Innova ESI Full time

Company Description

InnovaESI, a leading IT partner firm, focuses on providing digital transformation through end-to-end data solutions with a global presence in the USA, Canada, Mexico, India, and Singapore. The company is a joint venture of Enterprise Solutions, Inc., USA, and Innova, India, pioneers in Staff Augmentation. InnovaESI empowers businesses with innovative and sustainable IT solutions to drive digital transformation and enhance operations for growth.


Role Description

This is a full-time on-site role for a SAS Programmer at InnovaESI's Bengaluru location. The SAS Programmer will be responsible for statistical programming, analytical skills, data management, programming, and statistics tasks on a day-to-day basis.


Qualifications

JOB DESCRIPTION – SAS Programmer

 

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.