About Diagnostics at Owkin

Our ambition is to potentiate precision diagnosis in oncology with artificial intelligence applied to digital pathology. Pathology slide images, taken from biopsied or resected tissues, are a yet-untapped, ultra-high dimensional data modality that offer a huge potential for deep learning application to better understand disease, optimize patient care & improve treatment decisions.

We have for instance developed two products based on AI and digital pathology to tackle major challenges in precision oncology:

• The first one is about evaluating the risk of relapse in early breast cancer for a better adaptation of the therapeutic strategy. 
• The second one is about decreasing the burden of MSI screening for patients with Colorectal cancer. If detected, the MSI phenotype leads to a very specific care pathway with a treatment based on immunotherapy improving the chance of survival for the patient.

About the role:

As a Clinical Biostatistician Level II, you will play a central role in validating our AI-based diagnostic solutions and ensuring that they meet CE-IVD and FDA regulatory requirements. 

This will include creating experimental designs and clinical protocols, writing code, performing analyses, writing clinical study reports, and evaluating post-market studies.

In particular, you will:

• Work with the Product, Regulatory, Market Access, and Data Science teams to develop and implement our device performance evaluation strategy
• Lead study design, analysis, and report writing for analytical and clinical validation studies that will go into product technical files for CE-IVD and/or FDA submissions
• Lead the response to statistical issues arising in Regulatory, Quality, Clinical, and Market Access
• Prepare investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses to requests from regulatory agencies, local Institutional Review Board, and other health authorities
• Determine the relevance and contribution of data sets to clinical evaluation of device performance
• Perform post-market activities like post-market surveillance (PMS), periodic safety update report (PSUR), and post-market performance follow-up (PMPF) in association with other team members
• Consult with investigators to formalize analysis plans and reporting specifications; advises on choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
• Oversee or develop enhancements to statistical software by programming new techniques; maintain knowledge of current and emerging trends in statistical analysis methodology

Position is based in our Paris or Nantes offices or remotely.

About you

Required qualifications / experience:

• Master's degree in statistics, biostatistics, engineering or equivalent professional experience
• Good level of Python and/or R
• Knowledge of scientific reporting and manuscript preparation requirements and standards
• Familiarity with the Quality Management System and the various stages of medical device development
• Detail oriented 
• You are able to work independently and as part of a team
• Knowledge of data management principles and regulatory requirements for clinical trials and medical research.
• Fluent in English and French
• A good sense of humor, integrity and professionalism

Preferred qualifications/bonus:

• Prior experience with conducting clinical validation studies for CE-IVD and/or FDA for either a medical device or a drug a strong plus
• Knowledge on machine learning fundamentals 
• Knowledge of the new IVD or MD regulations in Europe as well as CLSI guidelines
• Experience with the IEEE 2801 "Recommended Practice for the Quality Management of Datasets for Medical Artificial Intelligence" standard, as well as the ADAM standards
• Experience producing evidence for reimbursement requests from health authorities

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