Statistical Programmer

5 giorni fa

Provincia di Reggio nell'Emilia, Emilia-Romagna, Italia Chiesi Tempo pieno

Overview

In this role you will lead SAS programming activities for clinical and safety data systems at Chiesi GRD, delivering high-quality data outputs for regulatory submissions. You will guide project-specific SAS work plans, maintain data integrity, and support SAP reviews and mock-up tables. You will collaborate across teams to ensure standardized data collection and compliant reporting, while driving best practices and data warehouse initiatives. This is a chance to shape data-driven decision making in a global rare diseases context and contribute to impactful therapies.

Retribuzione / Benefits

  • pension
  • private medical insurance
  • wellbeing programme
  • flexible benefits programme
  • relocation support
  • remote work options

Responsabilità

  • Establishes SAS programming needs for projects and develops work-plans to deliver outputs
  • Produces quality data outputs and preserves data integrity
  • Writes, validates, and maintains SAS programs for datasets, listings, tables, and graphs
  • Builds and maintains a library of SAS programs and related processes
  • Validates outputs and programs to support deliverables
  • Provides data collection and metadata package expertise for standardized submission-ready data
  • Contributes to SAP reviews and mock-up table/shell production
  • Develops standard edit checks and flags data issues indicating protocol adherence problems
  • Creates/adjusts processes to ensure CDISC-compliant submissions
  • Leads submission-related programming activities and oversees CRO programming activities
  • Maintains knowledge of regulatory requirements (GCP, GCDMP, CFR 21.11) and contributes to SOPs and work instructions
  • Supports data warehouse set-up and maintenance and develops novel tools to aid decision making

Requisiti fondamentali

  • Bachelor's Degree in a related field (Health Sciences, Statistics, Computer Science)
  • >7 years of Pharmaceutical/CRO experience
  • High level of SAS experience
  • Solid understanding of Data Management and Biostatistics processes
  • Experience cleaning/merging data from multiple sources
  • Experience creating and maintaining SAS reporting systems
  • Deep understanding of CDISC standards
  • Strong organizational and time-management skills
  • Ability to manage multiple priorities
  • Ability to work independently and in a team
  • SAS certification and/or A. Stat or P. Stat is an asset
  • English fluent
  • leadership
  • teamwork
  • problem-solving
  • SAS programming
  • Data management
  • CDISC standards