Job Details
Head of Statistics
4647
Posted: 22/04/2024
- £Competitive
- Harpenden, Hertfordshire, United Kingdom
- Permanent
Head of Biostatistics - Developing Biotech/Pharma - UK/EU - Remote / Flex / Hybrid
OVERVIEW:
We are working exclusively for a SME biotech who are looking for a Head of Biostatistics (would also consider an experienced Associate Director, or Senior Director / VP) to join as a senior member of a cross-functional asset team, reporting to the Chief Development Officer (CDO). You will contribute to the development of compounds within the oncology therapeutic area and drive the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. 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.
YOUR KEY RESPONSIBILITIES WILL INCLUDE:
WHO THEY ARE LOOKING FOR:
You’ll have strong people skills and be an expert team player, with demonstrated ability to be a part of multi-functional teams. You’ll have an entrepreneurial mindset and the ability to bring creative solutions to challenges. As a natural networker, you’ll forge strong relationships and alliances at all levels, internally & externally. You will also be highly motivated, passionate and energetic with an action oriented, results driven approach to everything you do.
YOUR SKILLS, KNOWLEDGE AND EXPERIENCE:
WHAT TO DO NEXT?
If this opportunity is of interest, please apply now with your CV as they are looking to arrange interviews soon.
Not what you are looking for? Please contact Aimee Weston at aimee@warmanobrien.com / +44 7806 790645 for a confidential discussion about potential opportunities.
OVERVIEW:
We are working exclusively for a SME biotech who are looking for a Head of Biostatistics (would also consider an experienced Associate Director, or Senior Director / VP) to join as a senior member of a cross-functional asset team, reporting to the Chief Development Officer (CDO). You will contribute to the development of compounds within the oncology therapeutic area and drive the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. 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.
YOUR KEY RESPONSIBILITIES WILL INCLUDE:
- Independently lead, initiate, and oversee the statistical support for the development of compounds within the Oncology therapeutic area.
- 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.
- Lead statistical related submission activities, and post-submission strategies/ preparations/defences.
- 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.
- Identify opportunities for the application of modelling and simulation to enhance study design.
- 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.
- Represent the company at professional societies, and in industry-wide technical discussions.
- As required, perform ad hoc and exploratory data analyses.
- Where required, provide statistical guidance to research facing statistical challenges.
- Where appropriate, provide training, seminars and/or coaching in statistical topics to non-statistical company staff.
WHO THEY ARE LOOKING FOR:
You’ll have strong people skills and be an expert team player, with demonstrated ability to be a part of multi-functional teams. You’ll have an entrepreneurial mindset and the ability to bring creative solutions to challenges. As a natural networker, you’ll forge strong relationships and alliances at all levels, internally & externally. You will also be highly motivated, passionate and energetic with an action oriented, results driven approach to everything you do.
YOUR SKILLS, KNOWLEDGE AND EXPERIENCE:
- PhD or MSc in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience. Involvement in immune oncology development programs desirable.
- 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.
- Can demonstrate excellent collaboration, organizational/ leadership abilities, and people skills.
- Demonstrated people management and leadership (direct or matrix) experience is preferred.
- 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.
WHAT TO DO NEXT?
If this opportunity is of interest, please apply now with your CV as they are looking to arrange interviews soon.
Not what you are looking for? Please contact Aimee Weston at aimee@warmanobrien.com / +44 7806 790645 for a confidential discussion about potential opportunities.
Aimee Weston
Principal Consultant in Biostatistics