Statistical Programmer

Statistical Programmer - Chiesi - Parma, Emilia-Romagna, IT

About us: Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy.

Le informazioni riportate di seguito illustrano i requisiti del ruolo, l'esperienza richiesta ai candidati e le qualifiche associate.

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. At 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 Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity 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.

Chiesi Global Rare Diseases

Chiesi 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. This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.

Rare 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.

What you will do

• Establish the SAS programming needs for a project and develop a work-plan to deliver SAS outputs to meet project deliverables.
• Responsible for the production of quality data outputs and preserving data integrity.
• Participate 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.
• Build and maintain a library of SAS programs and develop surrounding processes.
• Perform and document validation (quality control checks) of various outputs and programs to support Chiesi's deliverables.
• Support in providing expertise regarding data collection, set up and the impact on the data and metadata packages.
• Provide feedback to ensure the data is collected in a standardized manner and annotated as per standards required for submission.
• Contribute to the Statistical Analysis Plan via the review of the SAP and coordination of the production of mock-up table shells and TLFs.
• Build 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.
• Develop Case Report Tabulations (datasets, transport files) and associated metadata documentation for submissions using advanced knowledge of CDISC standards.
• Create/adjust processes as needed to ensure compliance with data submission standards.
• Provide technical expertise as needed for all programming issues.
• Participate in defining new SAS programming requirements for new, complex projects based on protocol and disease under study.
• Utilize advanced problem-solving techniques in the assessment, development and implementation of best practices for SAS, data management and reporting.
• Demonstrate ability to make sound decisions on complex issues related to daily activities and refer contentious issues with recommendations to the next level (issues that arise from discrepancy management process).
• Demonstrate leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the project.
• Show initiative in keeping self at the "leading-edge" of their field.
• Perform all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP and CFR 21.11 guidelines.
• Maintain and further develop in-depth knowledge of these documents.
• Participate in the development of SOP and Work Instructions for SAS related programming activities.
• Ensure compliance to these SOPs.
• Work as a member of a team to achieve all outcomes.
• Perform all work in accordance with all established regulatory and compliance and safety requirements.
• Fulfil a leading role in set-up and maintenance of data warehouse activities.
• Initiate and develop novel tools to support the decision making progress.
• Lead any submission related programming activities.
• Oversee any programming activities as performed by a CRO.

Who you need to have

• Bachelor's Degree in a related field required (e.g. Health Sciences, Statistics, Computer Science).
• Master's preferred.
• More than 7 years of Pharmaceutical/CRO experience.
• High level of SAS experience and expertise as demonstrated in previous work.
• A solid understanding of the Data Management and Biostatistics processes.
• Experience cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.
• Experience in creating and maintaining a SAS reporting system to generate listings, tables and flexible data outputs.
• In depth understanding of CDISC standards.
• Demonstrates effective organizational and time-management skills.
• Ability to manage multiple priorities in an efficient manner.
• Demonstrates ability to work independently and as part of a team.
• SAS certification and/or A. Stat or P. Stat accreditation are definite assets.
• English fluent.
• Location: Europe (flexible) - remote or hybrid.
• Other requirements.

Package & benefits

The 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.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more.

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.

Chiesi 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. xysqume

This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.

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