Statistical Programmer

26 ott - Reggio Emilia
Chiesi

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

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