MicroPort CRM - Senior Biostatistician (M/F)
LivaNova PLC
France-Clamart
il y a 7j

Description

LivaNova transforms technology into meaningful solutions by investing in product innovation that improves patient outcomes and is global, accessible, relevant, and breakthrough.

LivaNova’s three franchises Cardiac Rhythm Management (CRM), Cardiac Surgery (CS), and Neuromodulation (NM) have the people, skills, and drive to embrace new technologies and explore opportunities that advance patient care across the globe.

As part of our team of 4500 employees worldwide, your unique skills and contributions will help more than 5,000 hospitals provide the latest cardiovascular care in over 100 countries.

Within the Clinical Department, we are looking for a :

SENIOR BIOSTATISTICIAN (M / F)

Reporting to the Global Biometrics Director, the Senior Biostatistician will be :

  • Responsible, with limited direction, to ensure that deliverables in clinical studies or non-clinical projects meet : expectations in timelines and quality
  • operational efficiency

    alignment with project, clinical (if applicable) and statistical strategy and objectives

  • Responsible, with limited direction, to coordinate and manage processes and interfaces with other organizational units and relevant external partners
  • Essential Job Functions :

  • Act with limited direction in developing, conducting and executing clinical and non-clinical project activities : by providing :
  • biostatistical input into clinical trial and / or non-clinical project documentation as per functional role and responsibility

    efficient clinical trial design and sample size through Clinical Study Synopsis and Clinical Protocol, including the development of simulation programs to assess trial operating characteristics (as applicable)

    input in effective data collection and derivation

    thorough randomization plan and list

    accurate, clear and thorough statistical analysis plan with the most appropriate methodology and data presentation

    appropriate statistical monitoring of clinical trials

    support blind data review process

    unblind clinical trial

    ensure statistical analysis meets quality and regulatory requirements

    communicate, discuss and interpret (top-line) data and statistical results, including co-development of the clinical study report

  • Ensure, with limited direction, appropriate management and surveillance of external suppliers for outsourced biostatistical services
  • Communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in clear focused and articulate manner.
  • Provide programming instructions to Statistical Programmers, check and approve statistical programming deliverables
  • Recommend resource needs and analysis costs for trials
  • Ensure that all activities under responsibility are properly documented (traceability of changes, data specifications) according to the internal guidance documents
  • Exhibit routine and complex problem solving skills.
  • Keep abreast and apply innovative biostatistical methods and enhancements.
  • Understand and follow all Global Biometrics Quality Documents.
  • Review / contribute project management plan of clinical and non-clinical activities and ensure that deadlines are met.
  • Act, with limited direction, as internal expert :
  • Responsible to coordinate / manage operational or methodological initiatives

    Act as internal consultant for statistical methodology / operational activities

    Develop expertize on methodological / operational areas of interest

    For methodology initiatives : Increase the visibility of LivaNova by means of publication, posters presentations to conferences / Provide support in the development of complex trial design or complex project statistical activities Review trial design and statistical analysis plan delivered by the biostatistical team Support the development of documents for Regulatory Authorities interactions

  • Encourage and maintain quality in the biostatistical activities
  • Collaborate effectively with Global Biometrics internal and external partners in all activities where handling and programming of clinical data is needed
  • Work according to ICH-GCP, other international guidelines (e.g., ISO), working group recommendations (e.g., CDISC or Good Programming Practices) as well as internal quality system
  • Perform other tasks as per line management discretion
  • Ability to travel for business reasons
  • Knowledge, Skills, and Abilities Required :

    Technical skills :

  • Very solid mathematical and statistical skills
  • Able to understand and to implement statistical methods in the activities under responsibilities
  • Able to explain in simple terms complex statistical analytical methods and results
  • Able to understand and to implement statistical methods in the activities under responsibilities
  • Knowledge of statistical computer programs SAS and other statistical software (e.g., R, nQuery, PASS, etc.)
  • Competencies :
  • Decision making
  • Prioritization
  • Operational excellence
  • Strategic thinking
  • Problem solving
  • Customer satisfaction
  • Education :

    University degree (MSc) with excellent track record in mathematics, statistics, biometry or equivalent (PhD preferable)

    Experience :

  • More than 5 years of experience in life science industry in clinical development (either pharmaceutical, medical device or CRO)
  • Successfully demonstrated ability to perform clinical study activities under supervision of more senior biostatistician
  • Ensure implementation of guidelines and quality requirement in clinical and non-clinical activities
  • Ensure application of "state-of-the-art" biostatistical methodology in the activities under responsibilities
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