Proclinical are recruiting for a Principal Biostatistician to join a CRO. This role is on a permanent basis with the ability to work remotely from anywhere in the UK.
- Responsible for guiding biostatistics and programming actions for a program of studies of high complexity and/or high value with high impact.
- Evaluate project database structures, edit checks and data management coding conventions.
- Manage statistical analysis, comprehension of data and reporting outcomes.
- Author statistical strategies sections of integrated study reports as well as evaluate draft integrates study reports.
- Assist with responses to regulatory queries on the design of the program, and any labelling claims following proposals.
- Contribute to presentations at both client and investigator meetings.
- Prepare biostatistics contributions to the company's research submissions and contribute to proposal defense meetings as well as make presentations at marketing meetings with potential clients.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to an advanced degree level in a statistics, biostatistics, or similar discipline with demonstrable experience working within a pharmaceutical organisation.
- Acquaintance with oncology, as well as of guiding a regulatory proposal.
- Expertise on study designs, and statistical analysis applications in either one or more therapeutic areas.
- Communication skills both verbally and in writing.
- Interpersonal and project management capabilities.
- Know-how of numerous principles, theories and ideas in statistics and experimental design.
- Capable of implementing them to the development and analysis of clinical trials.
- Knowledge of clinical trials strategy, regulatory needs, statistics and statistical software packages, which involves SAS.
- Able to translate client's requirements into statistical practice and train clients in using statistics.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.