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Clinical SAS Programmer

72% Flex
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Mid-level (2-5 years)
Work from: 
India

Offer summary

Qualifications:

Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences, 4+ years experience in statistical programming.

Key responsabilities:

  • Interpret client requirements and provide statistical inputs
  • Develop, enforce quality standards and project timelines
  • Program and review analysis datasets and submissions
  • Provide training and guidance to junior staff
2COMS Consulting Pvt. Ltd. logo
2COMS Consulting Pvt. Ltd.
10001 Employees
About 2COMS Consulting Pvt. Ltd.
2COMS Consulting focuses on the #HumanSideOfThings – helping organizations become sustainable leaders by connecting them to the right talent. We are a Human Supply Chain management company with over 10,515+ employees, spread across seven locations. As an NSDC partner, we help more than 4000 professionals meet their career goals by connecting them with over 70 clients, daily. Our manpower solutions are customized and aligned with our clients’ requirements – financial management, continuous performance improvement, and integrated technology enablement. It is our continuous endeavours of the past 20 years that helped us strengthen our relationships with our partners and gain diversified experience spanning industries. For more information, visit the link below: https://www.2coms.com/
See more 2COMS Consulting Pvt. Ltd. offers

Job description

Logo Jobgether

Your missions

This is a remote position.

Location: PAN India (WFH)

JOB Description:

  • Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.
  • At least 4 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 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 review of 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

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Knowledge of Pharma IndustryData ValidationData EngineeringProcess ManagementSASR

Soft Skills

  • Analytical Thinking
  • Interpersonal Skills
  • Relationship Building
  • Self-Motivation
Are you interested?

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