Hiring Biostatisticians, Statistical Programmers, Project Managers & Data Managers
This role is to support our customer's German Health Technology Assessment (HTA) dossier activities. Having exposure to this area is a bonus, and will enable collaborating effectively, with colleagues from the different functions involved. Strong statistical skills and a flexible, customer-oriented mindset, but in full adherence to good statistical principles, will make you an asset for this role.
Responsibilities
* Providing statistical support to our customer's HTA activities, in particular for German HTA dossiers.
* Collaborate with all functions involved as part of interdisciplinary HTA project teams.
* Provide strategic statistical input in the development of HTA dossiers for the relevant HTA authorities in Germany according to AMNOG (Arzneimittelneuordnungsgesetz).
* Preparation and possible participation in consultations and meetings with the relevant authorities.
* Specification, quality control and delivery of (re-)analyses of clinical study data based on a Statistical Analysis Plan (SAP), working with the assigned programming teams.
* Participation in initiatives on topics like standard templates, analysis methods, presentation of results.
* Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
* Understand and follow applicable guidelines.
Qualifications
* Master’s degree in statistics or a related discipline. Ph.D. is desirable.
* 5+ years supporting drug development or HTA/post-marketing activities in the Pharmaceutical or Biotechnology industry.
* Experience with HTA activities and/or economic modelling is strongly desired. Experience related to HTA dossier and GBA (Gemeinsamer Bundesausschuss) interaction is an even stronger asset for this role.
* German language skill at native or near-native level (written and spoken) is a must.
* Good SAS and/or R programming skills for generation and QC of deliverables and exploratory activities/modelling.
* Solid understanding & implementation of CDISC requirements for regulatory submissions.
* Full commitment to driving effective delivery and contributing to the strategic goals of the customer's project.
* The ability to build strong external & internal relationships and motivate a regional or global team.
* Effective communicator: able to explain methodology and consequences of decisions in lay terms.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Science
Industries
* Pharmaceutical Manufacturing
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Frankfurt am Main, Hesse, Germany
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