Statistical Programmer

Chiesi Farmaceutici S.p.A.; À distance; EUR 60 000 - 80 000; Plein temps

Résumé du poste

An international pharmaceutical company is looking for a Lead Statistical Programmer to handle SAS programming tasks for clinical data systems. The ideal candidate will have over 7 years of experience in a Pharmaceutical or CRO environment and a Bachelor's degree in a relevant field. This role involves ensuring data integrity, contributing to Statistical Analysis Plans, and developing submission-related programming activities. The company offers a dynamic work environment with flexible working arrangements and a strong commitment to employee development.

Prestations

Continuous training and development

Flexible working approach

Support in relocation

Tax assistance service

Qualifications

• More than 7 years of Pharmaceutical/CRO experience required.
• Experience in creating and maintaining a SAS reporting system.

Responsabilités

• Establish SAS programming needs and develop work‑plan.
• Responsible for quality data outputs and integrity.
• Contributes to Statistical Analysis Plan and reviews.
• Develops Case Report Tabulations and associated metadata.

Connaissances

High level of SAS experience

Understanding of Data Management

Problem solving

Goal orientation

Strong interpersonal skills

Time-management skills

Formation

Bachelor’s Degree in Health Sciences, Statistics, or Computer Science

Master’s Degree

Outils

SAS

Description du poste

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Europe – remote, France

About us

Based in Parma, Italy, Chiesi is an international research‑focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees. To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas. Discover more here.

We are proud to have been awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared values and behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

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.

Purpose

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.

Main 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. 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 an 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.
• Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).
• 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.

Experience Required

>7 years of Pharmaceutical/CRO experience required.

Education

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

Languages

Not specified.

Technical Skills

• 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 is required.
• Strong interpersonal and verbal/written communication skills.
• 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.

Soft Skills

• Problem solving
• Goal orientation

What we offer

You would join a dynamic, fast‑growing, challenging and friendly environment. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well‑being. We want our people to come to work happy every day, and we know how important it is to find the right work‑life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people‑care services.