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.

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

Manager, Biomarker Statistical Programming

Key skills