Data Analysis Programmer
Pubblicato il 24-10-2026 - Chiesi Farmaceutici in Italia
ppBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p h3About us /h3 pChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. p pAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /We believe our differences make us stronger. p h3Chiesi Global Rare Diseases /h3 pChiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. /p pThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. /p pRare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. p h3This is what you will do /h3 pFunctions as a Lead Statistical Programmer, participates in SAS related programming activities for all clinical and safety data systems at Chiesi as well as activities in preparing data and metadata packages for regulatory submission.
The Principal Statistical Programmer is responsible for project-specific internal and external deliverables regarding SAS programming to be completed within budget and on time. /p h3You will be responsible for /h3 ul liEstablishes the SAS programming needs for a project and develops work-plan to deliver SAS outputs to meet project deliverables. /li liResponsible for the production of quality data outputs and preserving data integrity. /li liParticipates in the writing, validation and maintenance of SAS programs to generate SAS datasets, spreadsheets, data listings, tables and graphical displays of clinical trial, safety and post marketing data residing in all data systems owned by Chiesi GRD. /li liBuilds and maintains a library of SAS programs and develops surrounding processes. /li liPerforms and documents validation (quality control checks) of various outputs and programs to support Chiesi’s deliverables. /li liSupports in providing expertise regarding data collection, set up and the impact on the data and metadata packages. Provides feedback to ensure the data is collected in a standardized manner and annotated as per standards required for submission. /li liContributes to the Statistical Analysis Plan via the review of the SAP and coordination of the production of mock-up table shells and TLFs. /li liBuilds a library of standard edit checks in SAS to supplement edit checks in data systems owned by DM, Chiesi or in datasets received via CROs, looking for trends that could indicate problems with protocol adherence or data issues.
/Creates/adjusts processes as needed to ensure compliance with data submission standards. /li liParticipates in defining new SAS programming requirements for new, complex projects based on protocol and disease under study. /li liUtilizes advanced problem-solving techniques in the assessment, development and implementation of best practices for SAS, data management and reporting. /li liDemonstrates leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the project. /li liShows initiative in keeping self at the “leading-edge” of their field /li liPerforms all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP and CFR 21.11 guidelines. li liParticipates in the development of SOP and Work Instructions for SAS related programming activities. Ensures compliance to these SOPs. /li liPerforms all work in accordance with all established regulatory and compliance and safety requirements. /li liFulfil a leading role in set-up and maintenance of data warehouse activities. /li liInitiate and develop novel tools to support the decision making progress. /li liLeads any submission related programming activities. /li liOversees any programming activities as performed by a CRO. /li /ul h3You will need to have /h3 ul liBachelor’s Degree in a related field required (e.g. Health Sciences, Statistics, Computer Science). Master’s preferred. /li li7 years of Pharmaceutical/CRO experience. /li liHigh level of SAS experience and expertise as demonstrated in previous work. /li liA solid understanding of the Data Management and Biostatistics processes. /li liExperience cleaning and resolving data issues as well as merging data from different sources i