4DMT is looking for a statistician to provide strategic statistical input and oversee all statistical aspects of assigned programs, driving cross-functional collaboration and decision-making for robust drug development plans.
Requirements
- Hands-on familiarity with common and advanced statistical methodology.
- Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
- Strong knowledge of SAS programming concepts and techniques in the pharmaceutical; proficiency in tools such as SAS, EAST, and nQuery.
- Knowledge/experience of Retinal development, including global regulatory requirements and design and analysis of non-inferiority trials
Responsibilities
- Ensures expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) for critical studies in a program
- Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enables successful impact on robust drug development plans
- Maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results.
- Provides oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards.
- Leads and/or participates in the development and review of Policies, SOPs and other controlled documents for process improvement and operational efficiency.
- Supports the preparation and validation of statistical analyses for use in regulatory documents and scientific articles.
- Support internal ad-hoc and exploratory analysis.
Other
- 10+ years of pharmaceutical industry experience with a PhD, or 12+ years with an MS.
- Minimal 5% travel
- Equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
