Provide statistical support for German HTA (AMNOG) dossiers, collaborate with interdisciplinary teams, deliver and QC (re-)analyses per SAP, contribute to templates and methods, present methodology to stakeholders, and ensure compliance with guidelines.
Who Are You?
An experienced German-speaking Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support our customer's Health Technology Assessment (HTA) dossiers in Germany. You are motivated to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
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.
As a Senior Biostatistician, your responsibilities will include:
- 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
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- 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.
Cytel Cambridge, Massachusetts, USA Office
Cambridge, MA, United States
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