Statistical Programmer

15 ore fa

reggio 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