In this position, you will be responsible for coordinating and directing the work of the Biostatistics and Programming team on large and/or complex studies with high impact.
Prepare biostatistical input for the program design, protocol input such as sample size calculations and patient randomization schemes, and statistical aspects of case report forms.
Conduct a review of the project database structures, edit checks, and coding conventions for data management.
Develop statistical analysis plans, including derived data definition, and design of statistical tables, figures, and data listings.
Analyze, interpret, and report data in a statistical manner to make sure they are accurate.
Ensure that the statistical methods sections of integrated studies reports are written to the highest standard.
Ensure that integrated study reports are reviewed.
Respond to regulatory questions regarding the design of the program and any labeling claims following submission.
- An excellent understanding of a wide range of principles, theories, and concepts in statistics and experimental design; should be capable of applying these to the development and analysis of clinical trials.
- It is essential to have a solid understanding of clinical trial methodology, regulatory requirements, statistics, and statistical software packages, including SAS.
- An understanding of the regulatory submission process.
- It is essential that you are capable of translating clients' needs into statistics practice and educate clients on how statistics can be used in their everyday lives.
- Strong interpersonal and project management skills, as well as excellent verbal and written communication skills.
If you are having difficulty in applying or if you have any questions, please contact Tom Magenis at email@example.com
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.