Head of Biostatistics
4 weeks ago
Head of Biostatistics
Department: Clinical Development
Employment Type: Permanent - Full Time
Location: invoX Remote (Rest of world)
Reporting To: Robert Ilaria
DescriptioninvoX (invoX Pharma Limited) is on our way, through multiple acquisitions and investments, to creating an international scalable platform to build a portfolio of innovative and differentiated clinical and pre-clinical drug candidates that will improve lives by creating access to innovative medicines across key therapeutic areas, including oncology and respiratory.
To help continue our growth and success, we are looking for a Head of Biostatistics to join as a senior member of a cross-functional asset team, reporting to the Chief Medica Officer (CMO). You will contribute to the development of compounds within the oncology therapeutic area at invoX 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 third-party statisticians and data scientists to ensure high quality and timely deliverables, whilst managing resources, setting priorities, and ensuring consistency and adherence to standards therein.
invoX (invoX Pharma Limited) is a wholly-owned subsidiary of Sino Biopharmaceutical Limited, a global, top 50 pharmaceutical company with more than 24,000 employees. As invoX continues to grow, this is a compelling opportunity to work in a fast-paced business.
You have the potential to join our dedicated team on its journey achieve invoX’s vision to become a globally recognized, fully integrated pharmaceutical company, with an advancing pipeline of innovative products addressing unmet healthcare needs, directly improving patients’ lives.
Key Responsibilities- Develop and drive statistical strategy for the development of compounds within the invoX Oncology therapeutic area, from early to late phase studies.
- Provide statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results.
- Present strategic rationale for the design of clinical studies for internal meetings and for engagement with external regulatory bodies as needed.
- Provide statistical support for key regulatory documents, such as those required to support IND applications, End-of-Phase meetings, and regulatory submissions.
- Develop and update Statistical Analysis Plans for clinical studies and provide input and oversight of any third party involved in generating the necessary analytical data sets, tables, and figures.
- Plan and conduct statistical analysis (ISS, ISE), post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies.
- Responsible for writing the statistical portions of regulatory documents and submissions.
- Provide statistical input for generating written regulatory responses and attend regulatory meetings as needed to provide verbal responses to statistical questions.
- Identify opportunities for the application of modelling and simulation to enhance study design.
- Promote, investigate, develop, and implement novel statistical approaches or methodologies
- Where appropriate, provide guidance and management to statisticians, programmers, and data managers to ensure high quality and timely deliverables.
- Represent invoX at professional societies, and in industry-wide technical discussions.
- As required, perform ad hoc and exploratory data analyses.
- Where appropriate, provide training, seminars and/or coaching in statistical topics to non-statistical staff at invoX
You will have strong interpersonal skills and a 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.
- 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 interpersonal 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.
We get things done, we keep things simple and we are driven by the science. We are ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invoX a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.
Please note: While we will consider candidates from all locations and remote working is a potential possibility, we have a strong preference for candidates based in the US or UK due to the location of the rest of our team. Ideally, to help facilitate our collaborative working culture, we would like a candidate to be based at one of our invoX sites in Cambridge or London #J-18808-Ljbffr-
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