Hobson Prior are in search for a Statistical Science Director to join a fantastic biopharmaceutical organisation on a permanent basis. Our client is focused on providing access to advanced treatments.
Please note that to be considered for this role you must have the right to work in this location.
- The ideal candidate will be responsible for the overall quality and the timely delivery of the statistical analyses for the assigned products.
- Accountable for all statistical aspects within assigned products providing statistical, scientific and strategic expertise for randomized as well as non-randomized studies to quantify the benefit-risk value and uncertainty of the emerging product profile throughout all phases of the drug development process in compliance with the company's SOPs and regulatory requirements/guidelines.
- You will be responsible for leading the statistical thinking and contributions to the creation and development of TPP/TPC, Target Label and Clinical Development Plans as well as to the Regulatory and Commercial Strategies for the company's products.
- Provides leadership and project coordination to all statisticians working in the project, including in-house consultants and statisticians at CROs.
- The candidate will be responsible for the statistical content in the CSP and CSR.
- Provide leadership and project coordination to all statisticians working in the project, including in-house consultants and statisticians at CRO.
- Provide statistical and strategic input into the establishment of a focused, aligned and achievable Target Product Profile (TPP) and Target Labels.
- Any other assigned duties.
- Comprehensive knowledge of clinical and pharmaceutical drug development.
- Thorough knowledge of theoretical and applied statistics.
- Ability to find innovative approaches to study design and analysis.
- Good understanding of the regulatory environment within clinical development.
- Ability to be the statistical representative from the company at regulatory interactions.
- Ability to coach less experienced statisticians in all aspects of their role.
- Excellent written and oral communication skills.
- Strategic thinking and influencing skills.
- Ability to communicate statistical information to non-statisticians.
- Strong ability to collaborate and contribute in global cross-functional teams.
- Leadership skills.
- Excellent writing and oral communication in English.
- The ideal candidate will have a minimum of 8 years of experience as a statistician in the pharmaceutical industry are required.
- Previous leadership experience from project and/or line management is required.
- Extensive experience working in phase II, III and IV programs and/or studies is required.
- Extensive experience of clinical program and study design and data analysis in using a variety of designs and complex statistical techniques, with different types of data and issues is required.
- Extensive experience of regulatory submissions and previous attendance at meetings with regulatory authorities in more than one region, e.g. Europe, US, Japan, and China would be a strong advantage.
- Experience of major regulatory submissions and/or previous attendance at meetings with regulatory authorities is required.
- Experience working in all phases of clinical development, including PASS/PAES would be an asset.
- Experience of collaboration with statisticians and other functions at CROs around out-sourced clinical studies would be a plus.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.