Field Reimbursement Manager responsible for education and support on CAR - T reimbursement. Managing office staff interactions to ensure patient access in the Southeast Region for Johnson & Johnson.
About the role
- Manager Statistical Programming leading biomarker statistical programming activities for clinical development. Collaborating cross-functionally to deliver analyses and manage resources for compliance and quality assurance.
Responsibilities
- Lead biomarker data analysis projects, data integration and standardization.
- Provides consistency and quality assurance on biomarker programming activities.
- Generates the production of statistical output (e.g., tables, listings) for study reports and integrated summaries.
- Independently identifies issues in the analysis from previous experience and knowledge.
- Collaborates with Research Data Scientists, Biostatistics, Clinical Data Management, and Biomarker Scientists on analysis datasets and reporting.
- Participates in cross functional team meeting as a representative of Biomarker Stat Programming group.
- Provides trainings to junior programmers in biomarker statistical programming team.
- Lead and implement tool development activities within biomarker statistical programming group and collaborates in cross functional tool development.
- Responsible for all biomarker statistical programming activities within a therapeutic area.
Requirements
- PhD degree in Biostatistics, Computer Sciences or equivalent and 0+ years of relevant experience OR MS degree in Biostatistics, Computer Science or equivalent and 4+ years of relevant experience OR BS degree in Biostatistics, Computer Science or equivalent and 6+ years of relevant experience
- 5+ years of pharmaceutical or CRO experience
- Experience in bioinformatics, medical research at cancer & tumor immunology, immunogenicity & proteomics fields.
- Experience in clinical trials statistical programming and data analysis, with great understanding of clinical trial development in use of Biomarker from Phase I to IV
- Proficiency in SAS, R/python
- Advanced SAS and R programming experience preferred
- Knowledge of clinical trials FDA guideline, clinical trials related regulatory requirements and terminology
- Thorough understanding of CDISC standards, extensive experience in creating SDTM and ADaM datasets
- Oncology, hematology, or cell therapy experience strongly preferred
- Excellent communication, interpersonal & organizational skills
Benefits
- paid time off
- discretionary annual bonus
- discretionary stock-based long-term incentives
- company-sponsored medical, dental, vision, and life insurance plans
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