Berufsbezeichnung: Senior Statistician (m/w)

Arbeitsbeschreibung:
As one of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day. Your Responsibilities: - Programming all types of tables, listings, figures, and analysis datasets for statistical analysis in SAS - Validating SAS programs and output in the data Analysis - Maintaining, developing and validating SAS macros - Implementation of statistical modules in the data Analysis for clinical reports, abstracts and publications - Developing and amending SAP - Participate in the study design: perform sample size, calculations, discuss with the Clinical Project Managers Team and write statistical paragraph in the protocol, etc. - Review / write statistical paragraph in the Clinical Study Report - Consult other team members and Medical Affairs on statistics related issues - Support data cleaning - Participate in safety reporting if needed - Ensure quality of the data, programming codes, and the Outputs - Ensure that the statistical methods used are valid, applicable and in accordance with Good Clinical Practices and other guidances and regulatory requirements - Ensure timely and quality development and deliveries - Develop methods for artificial intelligence / machine learning - Plus, programming of additional edit checks in SAS - Participate in Data Management tasks Your Profile: - BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field - Minimum 4 years SAS experience and proven skills in the use of SAS within a statistical programming environment to develop and validate deliverables - Experience in contributing to statistical analysis plans and/or constructing technical programming specifications - Excellent knowledge of cardiovascular products, as well as statistical endpoints and setup of clinical studies - Excellent knowledge of ICH-GCP and applicable regulatory guidelines, knowledge in ISO 14155 is beneficia - Fluency in written and spoken English, knowledge of German an advantagel - Open minded, proactive, flexible team player with good communication skills and high attention to Details Are you interested? Please apply online! We are looking forward to welcoming you. We do not accept applications from Headhunters.

Angestelltenname: Biotronik AG