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Clinical Biostatistician Level II - Owkin

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Job Title
Clinical Biostatistician Level II
Job Location
Paris - Nantes - London - Remote in France and England
Job Description

About us

Owkin is an AI biotechnology company that uses AI to find the right treatment for every patient. We combine the best of human and artificial intelligence to answer the research questions shared by biopharma and academic researchers. By closing the translational gap between complex biology and new treatments, we bring new diagnostics and drugs to patients sooner.

Owkin has raised over $300 million and became a unicorn through investments from leading biopharma companies (Sanofi and BMS) and venture funds (Fidelity, GV and BPI, among others).

Owkin is seeking the best and brightest to join our fast-growing and dynamic team.

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

 #LI-MD1

What we offer

  • Flexible work organization and access to remote work
  • Friendly and informal working environment
  • Opportunity to work with an international team with high technical and scientific backgrounds

Recruitment Process & Security

  • Please complete the form and submit your CV.
  • Owkin is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, gender, sexual orientation, age, color, religion, national origin, protected veteran status or on the basis of disability.
  • Owkin is a great place to work. Unfortunately, being a coveted workplace means we are vulnerable to recruitment phishing scams. We urge all job seekers and candidates to be wary of potential scams. Most of these have individuals posing as representatives of prominent companies, including Owkin, with the aim of obtaining personal, sensitive, or financial information from applicants. These scams prey upon an individual’s desire to obtain a job and can sometimes “feel” like a genuine recruitment process. Some red flags are identified below. Should you encounter a recruitment process that claims to be for Owkin but is not consistent with the below, please do not provide any personal or financial information:
  • Legitimate Owkin recruitment processes include communication with candidates through recognized professional networks, such as LinkedIn. 
  • Communication is always through an official Owkin email address (from the @owkin.com domain), over the phone or though our applicant tracking system (Greenhouse).
  • The Owkin talent team do use platforms such as LinkedIn and Job Teaser, however if you have any concern or doubt about this contact, please ask for them to send an email from @Owkin.com.
  • The Owkin talent team will not solicit personal data from candidates during the application phase including, but not limited to, date of birth, social security numbers, or bank account information;
  • Legitimate Owkin interviews may be conducted over the phone, in person, or via an approved enterprise videoconferencing service (Google Meets). They will not occur via Signal, Telegram or Messenger
  • Owkin offers of employment are based on merit and only extended once a candidate has interviewed with members of the talent and hiring team. Offers will be extended both verbally and in written format.

 

If you think that you have been a victim of fraud, 

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Owkin Headquarters Location

New York, NY

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Owkin Company Size

Between 200 - 500 employees

Owkin Founded Year

2016

Owkin Funding Rounds

View funding details
  • Series B

    $50,000,000 USD

  • Series B

    $180,000,000 USD

  • Series A

    $18,000,000 USD

  • Series A

    $25,000,000 USD

  • Series A

    $13,000,000 USD

  • Series A

    $5,000,000 USD

  • Series A

    $11,000,000 USD

  • Seed

    $2,100,000 USD

Owkin's Investors

Company Collections For Owkin