ph3About us /h3pChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. /ppAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /ppDiversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. /ph3Chiesi Global Rare Diseases /h3pChiesi 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. /ppThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. /ppRare 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. Discover more here. /ph3What we are looking for /h3h3Functions as a Lead Statistical Programmer /h3pFunctions 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. /ppThe Principal Statistical Programmer is responsible for project-specific internal and external deliverables regarding SAS programming to be completed within budget and on time. /ph3You will be responsible for /h3ulliEstablishes the SAS programming needs for a project and develops work-plan to deliver SAS outputs to meet project deliverables. /liliResponsible for the production of quality data outputs and preserving data integrity. /liliParticipates 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. /liliBuilds and maintains a library of SAS programs and develops surrounding processes. /liliPerforms and documents validation (quality control checks) of various outputs and programs to support Chiesi’s deliverables.

/liliSupports 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. /liliContributes to the Statistical Analysis Plan via the review of the SAP and coordination of the production of mock-up table shells and TLFs. /liliBuilds 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. /liliDevelops Case Report Tabulations (datasets, transport files) and associated metadata documentation for submissions using advanced knowledge of CDISC standards. Creates/adjusts processes as needed to ensure compliance with data submission standards. /liliProvides technical expertise as needed for all programming issues. /liliParticipates in defining new SAS programming requirements for new, complex projects based on protocol and disease under study. /liliUtilizes advanced problem-solving techniques in the assessment, development and implementation of best practices for SAS, data management and reporting. /liliDemonstrates ability to make sound decisions on complex issues related to daily activities and refers contentious issues with recommendations to the next level (e.g. issues that arise from discrepancy management process). /liliDemonstrates leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the project. /liliShows initiative in keeping self at the “leading-edge” of their field /liliPerforms all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP and CFR 21.11 guidelines. Maintains and further develops and in-depth knowledge of these documents. /liliParticipates in the development of SOP and Work Instructions for SAS related programming activities. Ensures compliance to these SOPs. /liliWorks as a member of a team to achieve all outcomes. /liliPerforms all work in accordance with all established regulatory and compliance and safety requirements. /liliFulfil a leading role in set-up and maintenance of data warehouse activities /liliInitiate and develop novel tools to support the decision making progress. /liliLeads any submission related programming activities /liliOversees any programming activities as performed by a CRO /li /ulh3You will need to have /h3ulliBachelor’s Degree in a related field required (e.g. Health Sciences, Statistics, Computer Science).

Master’s preferred /lili7 years of Pharmaceutical/CRO experience /liliHigh level of SAS experience and expertise as demonstrated in previous work /liliA solid understanding of the Data Management and Biostatistics processes /liliExperience cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset /liliExperience in creating and maintaining a SAS reporting system to generate listings, tables and flexible data outputs /liliIn depth understanding of CDISC standards /liliDemonstrates effective organizational and time-management skills /liliAbility to manage multiple priorities in an efficient manner /liliDemonstrates ability to work independently and as part of a team /liliSAS certification and/or A. Stat or P. Stat accreditation are definite assets /liliEnglish fluent /li /ulh3Location /h3pEurope (flexible) – remote or hybrid /ph3Other /h3pThe package outlined below is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. /ppThe minimum salary for this role is €46.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. /ppThis role is eligible toparticipatein an annual bonus scheme, subject to company and individual performance. /ppIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more. /ph3What we offer /h3pNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. /ppWe provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. /ppChiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. /p /p #J-18808-Ljbffr

Statistical Programmer (Parma, IT)

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