Statistical Programmer
2 settimane fa
Reggio nell'Emilia, Emilia-Romagna, Italia
Chiesi
Tempo pieno
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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
* 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