Remote Director, Biostatistics & Trial Design

Syndax Pharmaceuticals; New York (NY); On-site; USD 235,000 - 260,000; Full time

Benefits offered by this job

Equity offering

Annual bonus

Excellent benefits

Job summary

Syndax Pharmaceuticals in New York seeks a Director, Biostatistics to lead statistical strategy across IND/NDA programs, design trials, and guide analyses. You will collaborate with cross-functional teams to ensure high-quality deliverables and regulatory-ready submissions.

This role requires a PhD or MS in Biostatistics with at least five years of industry experience, expertise in trial design, leadership skills, and proficiency in SAS.

Qualifications

• PhD or MS in Biostatistics or equivalent with substantial pharma/biotech experience.
• Strong grasp of advanced clinical trial design and statistical methods.
• Ability to lead cross-functional teams and understand development programs.

Responsibilities

• Provide strategic input to optimize trial designs in early and late phase studies.
• Collaborate with clinical trial teams to support study conduct.
• Oversee external CROs to ensure timely deliverables.
• Lead statistical aspects of regulatory submissions (IND/NDA/MAA) and data packages.
• Perform QC of statistical deliverables and validate key results.
• Develop SAPs, protocols' statistical sections, and study reports.
• Collaborate with Medical Affairs to support evidence generation and publications.
• Stay updated with regulatory requirements and advanced statistics.
• Lead Biostatistics initiatives and drive cross-functional process improvements.

Skills

Strategic thinking

Leadership

Communication

Cross-functional collaboration

Project leadership

Regulatory understanding

GCP knowledge

Multitasking

Education

PhD or MS in Biostatistics

Tools

SAS

Job description

Syndax Pharmaceuticals in New York seeks a Director, Biostatistics to lead statistical strategy across IND/NDA programs, design trials, and guide analyses. You will collaborate with cross-functional teams to ensure high-quality deliverables and regulatory-ready submissions.

This role requires a PhD or MS in Biostatistics with at least five years of industry experience, expertise in trial design, leadership skills, and proficiency in SAS.