SAS Programmer

Recordati; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company in Milan is seeking a Statistical Programmer to support the programming of outputs for clinical studies. This role requires a scientific degree and 3-5 years of experience in a CRO or pharmaceutical company. The ideal candidate is proficient in SAS and has a clear understanding of CDISC standards. You will be responsible for programming and validating outputs, as well as supervising dataset generation. This opportunity offers a collaborative work environment and a full-time contract.

Competenze

• 3-5 years of experience in a CRO or pharmaceutical company and clinical trials.
• Experience with regulatory guidelines in a pharmaceutical research setting.
• Collaborative and able to interact with all levels of the organization.

Mansioni

• Program and validate output for clinical studies.
• Supervise SDTM/ADaM dataset generation in compliance with CDISC.
• Develop standard SAS macros and templates.

Conoscenze

Proficient in programming in SAS System

Knowledge of CDISC standards

Good communication skills

Understanding of theoretical and applied statistics

Formazione

Scientific degree (Statistics, Mathematics, Informatics)

Strumenti

SAS

R

SQL

Descrizione del lavoro

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life.

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

• 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.
• 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.
• Develop standard SAS macros, templates and utilities and prepare the corresponding validation documents.
• Interact with the Statistician to prepare tables and listings according with the specification documents.
• Interact with the Data Manager in cleaning activities, external data management and reporting.
• Interact with the Drug Safety Unit to evaluate the data from the pharmacovigilance database.
• 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

Knowledge of CDISC standards and preferably GCP. Proficient in programming in SAS System. Optional R and/or SQL.

Required Behaviours And Competencies

Collaborative, good communicator and able to interact with all levels of the organization.

Required Languages

Fluent in English.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Information Technology

Industries

Pharmaceutical Manufacturing

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.