Hybrid Manager, Biomarker Statistical Programming

Posted 44 minutes ago

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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

Job title

Manager, Biomarker Statistical Programming

Job type

Experience level

Mid levelSenior

Salary

$133,195 - $172,370 per year

Degree requirement

Postgraduate Degree

Tech skills

Location requirements

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