Zheng(Lily) Zhang

Program statistician for an asset with a phase 2a study for Parkinson’s disease

• Act as the lead statistician, leading statistical efforts and representing statistical functions on program teams. Make strategic contributions to the clinical development plan.
• Serve as the biostatistical lead for regulatory submissions and inspections, ensuring compliance with global regulatory standards.
• Develop and review statistical analysis plans for individual studies. Created and edited statistical outputs shells.
• Oversee and quality control results from statistical programmers and CROs.
• Contribute to clinical study reports by authoring statistical sections and interpreting study results.
• Support the preparation of scientific publications and presentations.
• Manage relationships with CROs to ensure high-quality statistical outputs and compliance with study requirements.
• Manage direct reports by providing guidance and professional development.

Program Statistician for an asset with a phase 2b study for Multiple System Atrophy

• Act as the lead statistician, leading statistical efforts and representing statistical functions on program teams. Make strategic contributions to the clinical development plan.
• Serve as the biostatistical lead for regulatory submissions and inspections, ensuring compliance with global regulatory standards.
• Contribute to the development of clinical protocols by authoring the statistical methods section and reviewing other sections for statistical accuracy.
• Develop and review statistical analysis plans for individual studies. Create and edit statistical outputs shells.
• Provide statistical input during CRF design to ensure alignment with study objectives and analyze requirements.
• Oversee and quality control results from statistical programmers.
• Manage direct reports, providing guidance and professional development.

Trial Statistician for a Phase 2a double blind study for sleep disorder

• Develop and review statistical analysis plans. Create and edit statistical outputs shells.
• Oversee and quality control results from statistical programmers and CROs.
• Contribute to clinical study reports by authoring statistical sections and interpreting study results.
• Manage relationships with CROs to ensure high-quality statistical outputs and compliance with study requirements.

Trial statistician for a phase 2b study for a rare disease

• Developed integrated summaries of safety/efficacy (ISS/ISE). Create and edit statistical outputs shells.
• Oversee and quality control results from statistical programmers.

• Led biostatistical efforts for over thirty federally funded, large-scale cancer imaging clinical trials.
• The trial results were published in 35 peer-reviewed manuscripts.
• Manage multiple junior statisticians.

Trial Statistician for a Phase 3 study for Multiple Sclerosis

• Develop and review statistical analysis plans. Create and edit statistical outputs shells.
• Oversee and quality control results from statistical programmers and CROs.
• Contribute to clinical study reports by authoring statistical sections and interpreting study results.
• Manage relationships with CROs to ensure high-quality statistical outputs and compliance with study requirements.