Senior Biostatistician FSP (HTA, German-speaking)

Posted Yesterday
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8 Locations
In-Office or Remote
Senior level
Software • Analytics • Biotech
The Role
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.
Summary Generated by Built In
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.
 
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.

Skills Required

  • Master's degree in statistics or a related discipline
  • Ph.D. in statistics or related discipline
  • 5+ years supporting drug development or HTA/post-marketing activities in Pharma/Biotech
  • Experience with HTA activities and/or economic modelling
  • Experience with HTA dossier and G-BA interaction
  • German language skill at native or near-native level (written and spoken)
  • Good SAS and/or R programming skills for generation and QC of deliverables
  • Solid understanding and implementation of CDISC requirements for regulatory submissions
  • Ability to build strong external and internal relationships and motivate teams
  • Effective communicator able to explain methodology and consequences in lay terms

Cytel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cytel and has not been reviewed or approved by Cytel.

  • Healthcare Strength Health coverage is described as comprehensive, spanning medical, dental, vision, life and disability, with FSAs/HSAs also available. Plan quality is often characterized as good to excellent, which lifts the perceived value of the overall package.
  • Retirement Support A 401(k) with employer match is consistently part of the benefits package. The plan is also characterized as well managed, contributing to a sense of baseline retirement support.
  • Fair & Transparent Compensation Overall pay is characterized as decent-to-good and broadly competitive in parts of the business, with stronger alignment noted in senior technical tracks like biostatistics and programming. The total package is often framed as respectable rather than premium.

Cytel Insights

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The Company
HQ: Cambridge, MA
1,395 Employees
Year Founded: 1987

What We Do

Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com

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