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