Jobs
>
London

    Head of Biostatistics - England, United Kingdom - Warman O'Brien

    Default job background
    Description
    Head of Biostatistics - United Kingdom - Hybrid / Remote - Excellent Remuneration & Benefits

    I am working exclusively for a SME biotech who are looking for a Director of Biostatistics (Senior also considered) to join as a senior member of a cross-functional asset team, reporting to the Chief Development Officer (CDO).

    You will also be responsible for developing trial designs that address study objectives that will support regulatory approval, including contributing to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defences.

    You will provide guidance and management to CRO based statisticians and data scientists to ensure high quality and timely deliverables, whilst managing resources, setting priorities, and ensuring consistency and adherence to standards therein.


    Provide statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results.

    Present and defend complex statistical solutions to all levels of the company's governance, key stakeholders and external regulatory bodies in a clear, concise, complete, and transparent manner that provide influence on key decisions.

    Review/Develop the Statistical Analysis Plan, including the definition of derived data sets, and the design of statistical tables, figures, and data listings for clinical summary reports.

    Plan and conduct statistical analysis (ISS, ISE), post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies.

    Collaborate in writing regulatory document, reviews sections of regulatory submissions, attends meetings with regulatory agencies to support drug registration.

    Promote, investigate, develop, and implement novel statistical approaches/methodologies, for relevant statistical issues (in collaboration with academic groups, as needed).

    Where appropriate, provide guidance and management to statisticians to ensure high quality and timely deliverables.
    As required, perform ad hoc and exploratory data analyses.
    Where appropriate, provide training, seminars and/or coaching in statistical topics to non-statistical company staff.

    You'll have an entrepreneurial mindset and the ability to bring creative solutions to challenges.

    PhD or MSc in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.

    Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
    Excellent interpersonal, communication, writing and organizational skills.

    Demonstratable expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.

    Experience in preparing and participating in global regulatory agency interactions.

    Significant experience on a full development asset providing statistical guidance and input to the clinical development plan, regulatory Health Authority submissions (NDA/BLA/MAA) and defence and acted as the lead statistician on responding to submission-related questions from Health Authorities.



  • Emmes London, United Kingdom

    Overview: · **Head of Biopharma Biostatistics - Remote** · **UK Remote** · The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe ...

  • Warman O'Brien

    Head of Biostatistics

    3 weeks ago


    Warman O'Brien London, United Kingdom

    Job Description · Head of Biostatistics - UK/Remote · About the role: · I have recently partnered with a clinical stage, fast growing Biopharma company who are focused on developing immuno-oncology treatments and other therapies for cancer. In this position you will contribute ...

  • Warman O'Brien

    Head of Biostatistics

    3 weeks ago


    Warman O'Brien London, United Kingdom

    Head of Biostatistics - UK/Remote About the role: I have recently partnered with a clinical stage, fast growing Biopharma company who are focused on developing immuno-oncology treatments and other therapies for cancer. In this position you will contribute to the development of co ...

  • Warman O'Brien

    Head of Biostatistics

    3 weeks ago


    Warman O'Brien United Kingdom

    Head of Biostatistics - UK/Remote · About the role: · I have recently partnered with a clinical stage, fast growing Biopharma company who are focused on developing immuno-oncology treatments and other therapies for cancer. In this position you will contribute to the development ...

  • invoX Pharma Limited

    Head of Biostatistics

    3 weeks ago


    invoX Pharma Limited United Kingdom

    Head of Biostatistics · Department: Clinical Development · Employment Type: Permanent - Full Time · Location: invoX Remote (Rest of world) · Reporting To: Robert Ilaria · Description · invoX (invoX Pharma Limited) is on our way, through multiple acquisitions and investme ...

  • Warman O'Brien

    Head of Biostatistics

    3 weeks ago


    Warman O'Brien London Area, United Kingdom

    Head of Biostatistics - UK/Remote · About the role: · I have recently partnered with a clinical stage, fast growing Biopharma company who are focused on developing immuno-oncology treatments and other therapies for cancer. In this position you will contribute to the development ...


  • Emmes London, United Kingdom

    This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board. · Overview · Head of Biopharma Biostatistics - Remote · UK Remote · The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excelle ...

  • Warman O'Brien

    Head of Biostatistics

    2 weeks ago


    Warman O'Brien City of London, Greater London, United Kingdom

    Head of Biostatistics - UK/Remote · The following information provides an overview of the skills, qualities, and qualifications needed for this role. · About the role: · I have recently partnered with a clinical stage, fast growing Biopharma company who are focused on developing ...


  • Vertex Pharmaceuticals Paddington, United Kingdom

    Job Description · Associate Director - International Health Economics & Outcomes Research · - 12 month contract, starting asap_ · - Contractor_ · Job Purpose · This position will support the development of Health Economic materials for Vertex pipeline in Cystic Fibrosis and Hemat ...

  • Emmes

    Director Project

    3 weeks ago


    Emmes London, United Kingdom

    Head of Biopharma Biostatistics - Remote · UK Remote · The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We are a trusted partner to ...


  • Planet Pharma United Kingdom

    Planet Pharma are partnered with a mid-large medical device company who have seen over 55% growth recently and are hoping to implement more in the coming years. Our client is seeking Cath Lab Nurses to become Clinical Application Specialists and join their team in the United King ...

  • Planet Pharma

    Area Sales Manager

    5 days ago


    Planet Pharma united kingdom, United Kingdom

    Planet Pharma are partnered with a mid-large medical device company who have seen over 55% growth recently and are hoping to implement more in the coming years. Our client is seeking Area Sales Managers to join their team in the United Kingdom. You'll cover your own territory and ...

  • Planet Pharma

    Market Research

    1 week ago


    Planet Pharma London, United Kingdom

    Job DescriptionRole: Markets Research and Insights · Location: Slough · Type: Contract · Duration: 12 months · Planet Pharma are partnered with a leading pharmaceutical client who is seeking a Market Research & Insights Partner. The position is a hybrid role with 2 days on site ...


  • Planet Pharma united kingdom, United Kingdom

    One of valued global biotech clients are seeking Business Analyst to sit within their quality team. · Client · A successful immunology biotech that specialise in autoimmune disease and cancer. They are a really exciting fast growing Biotech that has grown by 70% in the past two y ...


  • Planet Pharma united kingdom, United Kingdom

    Planet Pharma are partnered with a global Pharmaceutical company who are sitting in the top 10 pharmaceutical companies in the world. We have a few statistical programmer roles within this company at varying seniority levels. · The Candidate : · Must have experience with SAS and ...


  • Planet Pharma london, United Kingdom

    Job DescriptionOne of our key pharmaceutical clients is seeking a Key Account Manager to join them to have responsibility over the London area. · Role · The role is a Key Account Manager role for Urology in London. The role would focus on being the local NHS expert and having res ...


  • Planet Pharma london, United Kingdom

    One of our key pharmaceutical clients is seeking a Key Account Manager to join them to have responsibility over the London area. · Role · The role is a Key Account Manager role for Urology in London. The role would focus on being the local NHS expert and having responsibility for ...


  • Haleon Weybridge, United Kingdom

    **Associate Director, Biostatistical Programming**: · - Weybridge, United Kingdom · - Research and Development · gsknch · **Job Description**: · **Site Name**: Weybridge St Georges Avenue · - **Posted Date**: Nov Hello. We're Haleon. A new world-leading consumer health company. S ...


  • UCB S.A. Slough, United Kingdom

    **Make your mark for patients** · We are looking for a **Statistical Methodology Lead** who is curious, ambitious, and innovative, to join us in **our Statistical Sciences and Innovation (SSI) team **to be based in one our Research and Developent hubs in the UK, Belgium, Germany ...


  • Planet Pharma united kingdom, United Kingdom

    Title: Executive Director, Clinical Operations Development · Role: Permanent / Full time · Company: Global Biotech · Location: Remote (in Belgium, UK, Netherlands, Italy, Germany) · Planet Pharma has collaborated with a Global Pioneering Biotech headquartered in Europe. Our clien ...