Head of Biostatistics - City of London, Greater London, United Kingdom - Warman O'Brien

Description

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 compounds within the oncology therapeutic area and drive the design of innovative and efficient clinical trials.

As the Head of Biostatistics, you will be joining as a senior member of a cross-functional asset team, reporting to the Chief Medica Officer (CMO).

• Develop and drive statistical strategy for the development of compounds within the 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.
• 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.
• Where appropriate, provide guidance and management to statisticians, programmers, and data managers to ensure high quality and timely deliverables.
• Where appropriate, provide training, seminars and/or coaching in statistical topics to non-statistical staff

• 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.
• 10+ years of experience in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry, or healthcare experience.
• 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.

• Salary up to £110,000
• Collaborative and inspirational working environment / atmosphere
• Excellent employment package and work/life balance