Hobson Prior are seeking an Associate Director of Statistics to join a leading biopharmaceutical company that specialise across a range of therapeutic areas, who are determined to improve patients lives by delivering pioneering medicines. This position will be on a permanent basis, located in Paris.
- Represent as a statistical adviser to global project teams and clinical study teams for appropriate project development and make contributions to the statistical work for other projects as required.
- In co-operation with the Early/Medical Development Director and other groups, ensure that development plans have a high quality, timely and robust statistical input.
- Ensure that clinical study protocols are developed with statistical input as early as possible, and that statistical review and approval of other relevant study documents, is conducted to high quality.
- Lead project and study level activities with support from external vendors’ statisticians.
- Deliver statistical input for Selection and evaluation of external vendors and take responsibility for ensuring that the CRO statistical deliverables meet project specifications.
- Ensure that the Clinical Development Department has the functional specifications, quality standards and statistical input to the CRO evaluation and management process in a time frame and in accordance with clinical study team outsourcing strategy.
- Co-ordinate the clinical research components of regulatory activities with respect to statistical methods, results and evaluation.
- Provide the written and verbal elements of regulatory submissions around the world.
- Plan, schedule and track all statistical activities, to ensure high quality, timely and accurate completion of statistical deliverables.
- Present statistical methods used in clinical studies to Regulatory bodies when required: this includes the FDA and EMEA as well as national bodies as appropriate.
- Lead the Statistical input to the regulatory review process, addressing Regulatory Bodies questions in a timely technically sound and clearly presented manner.
- Language: English, French
- Minimum of 5 years as a Statistician in a pharmaceutical company or in an external vendor, with support of study in oncology.
- A minimum of a honors degree in a relevant subject.
- Several years of experience in a similar position would be ideal.
- Experience of successful involvement in submission processes.
- Prior experience of participating in selection and management of external vendors, ideally applied in Oncology, experience in adaptive designs and innovative designs.
- Life Science and/or Information Technology graduate would be ideal.
- In-depth knowledge of Statistics applied to clinical studies.
- High knowledge of international standards (ICH, GCP, CDISC) and regulations related to clinical studies.
- High level of expertise in the use of the statistical software.
- High level of expertise of oversight and management of external vendors.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.