Director Biostatistics

Director Biostatistics at Green Key Resources Director Biostatistics at Green Key Resources in Winchester, Massachusetts Posted in 2 days ago.

Type:

full-time

Job Description:

A global, commercial?stage biopharma company focused on serious genetic and cardiometabolic diseases is seeking a Director of Biostatistics to lead statistical strategy and execution across complex, late?phase clinical programs. This leader will shape clinical development plans, design innovative trials, guide statistical analysis, and play a key role in global regulatory submissions.

Key Responsibilities:

Drive statistical strategy for large and/or complex Phase 2/3 clinical programs. Partner closely with Clinical Development, Regulatory, and Clinical Operations to design innovative, efficient clinical trials. Author statistical sections of protocols and statistical analysis plans. Oversee randomization/stratification schema and collaborate on eCRF design. Provide ongoing statistical guidance throughout trial conduct. Work with statistical programmers to develop ADaM specifications and ad hoc analyses. Interpret and communicate clinical data to support regulatory filings, publications, and internal decision?making. Contribute to clinical study reports, DSURs, briefing documents, and other regulatory deliverables. Lead statistical support for global submissions (e.g., NDA, MAA). Represent the company in discussions with regulators, external partners, and key opinion leaders. Collaborate cross?functionally with research, preclinical, clinical pharmacology, medical affairs, and commercial teams on statistical questions. Manage timelines and ensure high?quality statistical deliverables across programs. Key Qualifications Advanced Degree in Statistics, Biostatistics, or related field (or equivalent experience). Minimum of 8 years of biostatistics experience in the pharmaceutical/biotech industry. Strong background in late?phase clinical trial design and execution. Hands?on experience supporting regulatory submissions. Proficiency in SAS and R programming . Experience interacting with FDA and international regulatory agencies would be a huge plus. Excellent communication skills and the ability to influence cross?functional teams.