At a Glance
- Tasks: Support German HTA dossier activities and collaborate with interdisciplinary project teams.
- Company: Leading pharmaceutical company focused on innovative health solutions.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Join a dynamic team with a commitment to excellence and strategic goals.
- Why this job: Make a real impact in healthcare by contributing to important HTA projects.
- Qualifications: Master’s degree in statistics, 5+ years in drug development, and strong German language skills.
The predicted salary is between 60000 - 80000 £ per year.
Role Overview
Senior Biostatistician responsible for supporting our customers’ German Health Technology Assessment (HTA) dossier activities.
Responsibilities
- Provide statistical support to the customer’s HTA activities, especially for German HTA dossiers.
- Collaborate with all functions 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).
- Prepare and possibly participate in consultations and meetings with the relevant authorities.
- Specify, quality‑control, and deliver (re‑)analyses of clinical study data based on a Statistical Analysis Plan (SAP), working with the assigned programming teams.
- Participate in initiatives on topics such as standard templates, analysis methods, presentation of results.
- Utilize strong communication skills to present and explain methodology and consequences of decisions.
- Understand and follow applicable guidelines.
Qualifications
- Master’s degree in statistics or related discipline (Ph. D. desired).
- 5+ years supporting drug development or HTA/post‑marketing activities in the pharmaceutical or biotechnology industry.
- Experience with HTA activities and/or economic modelling strongly desired; experience with HTA dossier and GBA interaction is an even stronger asset.
- German language skill at native or near‑native level (written & spoken) is required.
- Proficiency in SAS and/or R programming for generation and QC of deliverables and exploratory activities/modeling.
- Solid understanding and implementation of CDISC requirements for regulatory submissions.
- Full commitment to driving effective delivery and contributing to strategic goals of the customer's project.
- Ability to build strong external and internal relationships and motivate a regional or global team.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
- #J-18808-Ljbffr
We think you need these skills to ace Senior Biostatistician FSP (HTA, German-speaking)
Statistical Support
German Health Technology Assessment (HTA)
Interdisciplinary Collaboration
Strategic Statistical Input
Statistical Analysis Plan (SAP)
Quality Control of Clinical Study Data
SAS Programming
