Our client is a recognized yet growing biotech company leading the advancement of a new class of medicines. They are looking for a Biostatistician at the Director level to assist with the processing of all aspects of statistical activities in support of clinical trials. This company has several submissions and product launches scheduled and this role presents the opportunity to head a Phase III program into NDA submission. This role also has excellent outlook both internally and externally and offers the chance to have direct contact with the FDA. This position is flexible depending on experience.
The Director of Biostatistics will be responsible for:
- Administers production of, or makes contributions to statistical sections of protocols, clinical study reports, and statistical analysis plan
- Generates or confirms sample size/power calculations and randomization schemes
- Operates quality control checks of SAS code and output generated by Statistical Programmers
- Performs ad-hoc and exploratory statistical analyses as necessary
- Represents Statistics within clinical study teams
- Work hand in hand with Data Management and Stat Programming, to certify final databases, analyses, and reports are accurate
- Involved with all aspects of the process including offering support for the biostatistics and the development teams as necessary
The Director of Biostatistics should have the following qualifications:
- Master's degree in biostatistics or statistics, with at least 8 years of directly related experience in the pharmaceutical industry; Ph.D. with at least 5 years of experience
- Expert level of knowledge in regards to drug development processes and regulatory requirements, including ICH/GCP guidelines
- Ability to work both autonomously and within a team environment
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint), efficient in preparing presentation materials
- Fluent in English both written and verbally
- Familiarity with CDISC-ADaM data standard specifications
- Experience with phase III trials is a necessity
- NDA submission experience is strongly preferred
If you are interested in the Director of Biostatistics role, then please don't wait to apply.
