Principal Biostatistician

George Higginson is currently searching for a highly experienced Principal Statistician for an up-and-coming Biotech based in Cambridge, specialising in the Immunology therapeutic space. With a newly forming Biostatistics team, you will come in and single handily lead their Phase III studies forward. For them, the Principal Biostatistician will be responsible of the oversight and management of biostatistics activities to ensure high quality design, analysis and interpretation of sponsored clinical trials.

**Main Responsibilities**:

- Statistical contribution to the design, analysis and interpretation of clinical studies, including the writing the statistical sections of protocols, SAPs and study related activities.
- Oversight and review of vendor statistical activities, with accountability for study level timeliness and quality of statistical deliveries.
- Act as key contact for biostatistics vendors to ensure effective communication between us and the biostatistics vendors.
- Provide statistical insight and exploratory analyses of completed and ongoing studies.
- Provide effective communication and visualisation of data and statistical analyses within our company and support for publications and presentations.
- Communicate progress and identify risks and issues arising on clinical trials to the Director of Clinical Operations and other development team members as appropriate.

**Requirements**:

- Postgraduate degree in statistics or related discipline.
- Substantial experience of clinical biostatistics in the pharmaceutical/biotech industry.
- Experience of managing outsourced biostatistics activities.
- Experience with Phase III clinical trials is essential.
- Experience in Dermatology/Rheumatology clinical trials would be an advantage.
- Robust knowledge of GCP and related regulatory standards for clinical biostatistics governing clinical trials in the UK, EU & USA.
- Programming experience with SAS and/or R.
- Excellent oral and written communication skills.
- Ability to interpret, process and present data in innovative ways to meet the needs of multiple stakeholders.
- Highly organised, able to prioritise work, work well under pressure and meet deadlines Independent, self-starter with a proactive, problem-solving approach.
- Influencer with ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.
- Ability to see complex projects to completion, and to work on a broad range of tasks within a project.

**How To Apply**:
George Higginson
AL Solutions