Senior Biostatistician (HTA German Speaking)

Cytel; München; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading pharmaceutical and biotechnology company in München is seeking a Senior Biostatistician to support HTA dossier activities. This role involves providing strategic statistical input, collaborating with interdisciplinary teams, and ensuring quality analysis of clinical data. The ideal candidate should have at least 5 years of experience in HTA and drug development, along with strong statistical skills and fluency in German. This position offers an opportunity to contribute to impactful health assessments and collaborate with various stakeholders.

Qualifikationen

• 5+ years supporting drug development or HTA/post-marketing activities.
• Experience with HTA activities and/or economic modelling is strongly desired.
• Solid understanding of CDISC requirements.

Aufgaben

• Provide statistical support to HTA activities for German dossiers.
• Collaborate with interdisciplinary HTA project teams.
• Provide strategic statistical input for HTA authorities in Germany.
• Participate in consultations and meetings with relevant authorities.
• Deliver quality-controlled analyses based on a Statistical Analysis Plan.
• Present and explain methodology and decisions effectively.

Kenntnisse

Strong statistical skills

German language skills (native or near-native)

Good SAS programming skills

Good R programming skills

Effective communication skills

Ausbildung

Master’s degree in statistics or a related discipline

Ph.D. (desirable)

Tools

SAS

R

Jobbeschreibung

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

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

Qualifications

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.