Statistical Programmer

Chiesi Farmaceutici S.p.A.; Parma; On-site; EUR 41,400 - 50,600; Full time

Benefits offered by this job

Annual bonus

Relocation support

Private medical insurance

Job summary

Chiesi Farmaceutici S.p.A. in Parma, Italy, is seeking a Lead Statistical Programmer to drive SAS programming across clinical and safety data systems and prepare data packages for regulatory submission. You will lead project deliverables, ensure data quality and regulatory compliance.

The role requires extensive SAS expertise, CDISC knowledge, and experience with data management and reporting. You will mentor team members, develop standard programs, and collaborate with CROs to deliver on time

Qualifications

• Bachelor’s Degree in a related field required (Health Sciences, Statistics, Computer Science).
• 7 years of Pharmaceutical/CRO experience.
• High level of SAS experience and expertise.
• Solid understanding of Data Management and Biostatistics processes.
• Experience cleaning and resolving data issues and merging data from different sources.
• Experience 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 independently.
• SAS certification and/or A. Stat or P. Stat accreditation are definite assets.

Responsibilities

• Establishes the SAS programming needs for a project and develops work-plan to deliver SAS outputs to meet project deliverables.
• Responsible for the production of quality data outputs and preserving data integrity.
• Participates 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.
• Builds and maintains a library of SAS programs and develops surrounding processes.
• Performs and documents validation (quality control checks) of various outputs and programs to support Chiesi’s deliverables.
• Supports in providing expertise regarding data collection, set up and the impact on the data and metadata packages.
• Contributes to the Statistical Analysis Plan via the review of the SAP and coordination of the production of mock-up table shells and TLFs.
• Builds 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.
• Develops Case Report Tabulations (datasets, transport files) and associated metadata documentation for submissions using advanced knowledge of CDISC standards.
• Provides technical expertise as needed for all programming issues.
• Participates in defining new SAS programming requirements for new, complex projects based on protocol and disease under study.
• Utilizes advanced problem-solving techniques in the assessment, development and implementation of best practices for SAS, data management and reporting.
• Demonstrates ability to make sound decisions on complex issues related to daily activities and refers contentious issues with recommendations to the next level.
• Demonstrates leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the project.
• Shows initiative in keeping self at the “leading-edge” of their field
• Performs all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP and CFR 21.11 guidelines.
• Participates in the development of SOP and Work Instructions for SAS related programming activities. Ensures compliance to these SOPs.
• Works as a member of a team to achieve all outcomes.
• Performs 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.
• Leads any submission related programming activities.
• Oversees any programming activities as performed by a CRO.

Skills

SAS programming

SAS data management

Regulatory data submission

CDISC standards

Project leadership

Education

Bachelor’s degree in Health Sciences/Statistics/Computer Science

Master’s degree preferred

Job description

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, 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. 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. Discover more here.

This is what you will do

Functions 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.

You will be responsible for

• Establishes the SAS programming needs for a project and develops work-plan to deliver SAS outputs to meet project deliverables.
• Responsible for the production of quality data outputs and preserving data integrity.
• Participates 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.
• Builds and maintains a library of SAS programs and develops surrounding processes.
• Performs and documents validation (quality control checks) of various outputs and programs to support Chiesi’s deliverables.
• Supports 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.
• Contributes to the Statistical Analysis Plan via the review of the SAP and coordination of the production of mock-up table shells and TLFs.
• Builds 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.
• Develops 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.
• Provides technical expertise as needed for all programming issues.
• Participates in defining new SAS programming requirements for new, complex projects based on protocol and disease under study.
• Utilizes advanced problem-solving techniques in the assessment, development and implementation of best practices for SAS, data management and reporting.
• Demonstrates 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).
• Demonstrates leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the project.
• Shows initiative in keeping self at the “leading-edge” of their field
• Performs 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.
• Participates in the development of SOP and Work Instructions for SAS related programming activities. Ensures compliance to these SOPs.
• Works as a member of a team to achieve all outcomes.
• Performs 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.
• Leads any submission related programming activities.
• Oversees any programming activities as performed by a CRO.

You will need to have

• Bachelor’s Degree in a related field required (e.g. Health Sciences, Statistics, Computer Science). Master’s preferred.
• 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.

Location

Europe (flexible) – remote or hybrid

Other

The 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.

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.

What we offer

No 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.

We 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.

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

Discover all our job opportunities