1. Reviews protocols and other study documents that are developed in collaborations of business alliances. Leads and oversees interactions with respect to statistical discussions. Provides statistical supports for regulatory submissions in the collaborations.
2. Provides statistical supports for clinical trials and drug development plans within the clinical development. Works with the clinical, project management, and data manager teams on strategic designs of studies; develops, reviews and/or approves study documents such as clinical study protocols, statistical analysis plan, CRF, edit check specification, data management plan, final database validations, final study report. Performs statistical analyses.
3. Influences the proper use of statistics throughout Eisai’s neurology business group; contributes to the development of departmental standards and guidelines.
4. Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs.
5. Functions as lead statistician in global registration trials and manages all related statistical activities.
6. Leads and oversees preparations of inputs for regulatory documents and meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses.
7. Comprehensively assesses options and analytical strategies and identify team training needs and recommends solutions.
8. Provides strategic input and supports exploration of methods to improve Biostatistics operational efficiency.
• PhD with 10+ years or MS with 15+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment.
• Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process.
• Experience with CRO oversight and FDA submission preferred.
• Excellent technical writing and verbal communication skills.
• Strong teamwork ability/commitment and individual initiative.
• Strong organizational skills with ability to effectively manage multiple studies.
• Excellent programming skills in SAS or R.