SAS Programmer

Recordati; Milano; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Recordati is seeking a skilled Statistical Programmer to drive the programming of outputs (tables, listings, figures) and build SDTM/ADaM datasets for clinical studies. The role involves collaborating with statisticians, data managers, and safety teams to ensure CDISC-compliant deliverables and robust validation of programming utilities.

Ideal candidates have 3–5 years in CRO/pharma settings, strong SAS skills, and familiarity with CDISC and GCP guidelines.

Qualifikationen

• Clear understanding of theoretical and applied statistics and regulatory guidelines in pharmaceutical research; expert in NDA development and submission.

Aufgaben

• Program and validate the output (tables, listings, figures) to support data cleaning and statistical analyses.
• Supervise generation of SDTM/ADaM datasets and related documents per CDISC guidelines and CRO outputs.
• Develop standard SAS macros, templates, and utilities with validation documents.
• Interact with the Statistician to prepare tables/listings per specification documents.
• Collaborate with the Data Manager on data cleaning and external data management.
• Coordinate with the Drug Safety Unit to evaluate pharmacovigilance data.
• Lead development, maintenance, and adherence to divisional SOPs and guidelines.

Kenntnisse

SAS programming

CDISC standards

Statistical analysis

GCP familiarity

Communication

Ausbildung

Statistics/Mathematics/Informatics degree

Tools

SAS System

R (optional)

SQL (optional)

Jobbeschreibung

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

Job Purpose

We are looking for a Statistical Programmer that will be in charge of the programming of the output (tables, figures, listings) and generating the additional datasets related to the Company’s clinical studies on new drugs or marketed drugs by the Group’s companies followed by the CROs or directly including pooling of more studies. The person will improve and update the technical know-how about new programming techniques.

Key Responsibilities

• You will program and validate the output (tables, listings and figures) to support the data cleaning and the statistical analyses required for clinical studies, publications, Regulatory and Market Access requests
• You will supervise the generation of the SDTM/ADaM datasets and related documents in compliance with CDISC guidelines as well as the output prepared by the CRO.
• You will develop standard SAS macros, templates and utilities and prepare the corresponding validation documents
• You will interact with the Statistician to prepare tables and listings according with the specification documents
• You will interact with the Data Manager in cleaning activities, external data management and reporting.
• You will interact with the Drug Safety Unit to evaluate the data from the pharmacovigilance database.
• You will lead efforts in the development, maintenance and adherence to divisional SOPs and guidelines.

Required Education

Scientific degree (Statistics, Mathematics, Informatics)

Required Skills And Experience

3-5 years of experience in a CRO or pharmaceutical company and clinical trials.

You have a clear understanding of theoretical and applied statistic and regulatory guidelines in a pharmaceutical research setting; you are expert in the development and submission of NDA

Technical Competencies

You have knowledge of CDISC standards and preferably GCP.

You know programming in SAS System. Optional R and/or SQL

Required Behaviours And Competencies

You are collaborative, good communicator and able to interact with all levels of the organization.

Required Languages

Fluent in English

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.