BeOne is a rapidly growing company looking for an experienced professional to lead the statistical programming project team. The Associate Director, Statistical Programming Project Lead will be responsible for a product area and support multiple indication development programs. The role requires a collaborative and motivated individual with a passion for fighting cancer.
Requirements
- Collaborate with lead project Biostatistician in project strategic planning
- Provide overall guidance to the programming team in creation, implementation, and maintenance of programming development plans
- Represent the statistical programming team at Study Management Team and Clinical Development meetings
- Contribute to the development and implementation of programming resource algorithms
- Collaborate with programming managers and project leads to lead the effort of project resource planning and tracking
- Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables
- Contribute to strategies for programming related matters in submission to regulatory agencies, publications and other communications as needed
- Understand and execute department-, product- and study-level macros and utilities
- Write, test and validate product- and study-level macros and utilities
- Be a technical resource for programming groups to provide advice on complex programming tasks and/or standards
- Assist in the review of key study-related documents produced by other functions
- Oversee the projects for the creation of analysis datasets, production/validation of output, and review of annotated case report forms
- Lead the statistical programming support of FDA/EMEA/CDE regulatory submissions follow CDISC standards
- Contribute to departmental process and standards initiatives such as tools and CDISC standards
- Collaborate and support the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming
- Oversee the work in support of clinical trials, ad-hoc analysis requests, data validation, etc. in accordance with all relevant statistical regulatory guidance and standards
- Lead the development of TAUG (therapeutic area users guide) following CDISC Industry standards
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
