JVT Advisors

Contract Senior/Principal Statistical Programmer

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Location: Billerica, Massachusetts 01821
Employment Type: Contract

Job Description

Contract Length:  6 months remote to start

Job Summary:  As a Principal or Senior Programmer you will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors.

Responsibilities:

  • Input into and negotiate statistical programming timelines.
  • Ensure that timelines are adhered to coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
  • Monitor project resourcing, project budgets, and identify changes in scope.
  • Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards.
  • Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.

 

Requirements:

  • Proficiency in SAS
  • Knowledge of the programming and reporting process
  • Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
  • Strong leadership skills
  • Excellent analytical skills
  • Effective time management in order to meet daily metrics or team objectives
  • 5 plus years proficiency in SAS programming
  • 2+ years of ADaM, CDISC or SDTM
  • Lead experience in a Pharma setting

Chintan “Calvin” Raval

Vendor Operations Manager/Senior Recruiter

As the vendor manager for the Contract Recruiting team, Chintan is responsible for contract negotiation, continuing to expand relationships with IT service providers, and functional reporting including metrics for billability, operational issues, and investigated root causes.

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