Job Description

Job Title: Director, Biostatistics

Location: King of Prussia, PA (5 days/week onsite) - Relocation Assistance Available

Work Status: Visa Sponsorship Available

Overview:

A leading biopharmaceutical company is seeking an experienced Director of Biostatistics to drive the statistical strategy, design, and analysis of clinical trials across all phases. This critical, onsite leadership role offers the opportunity to impact pivotal programs, contribute to regulatory submissions, and shape biostatistical standards across the organization.

Key Responsibilities:

• Lead statistical design, analysis, and interpretation of clinical trial data (Phases I–IV).
• Develop and review protocols, statistical analysis plans, and final study reports.
• Collaborate cross-functionally with clinical, regulatory, and data management teams.
• Provide strategic input for regulatory filings and interactions with health authorities.
• Manage statistical activities and deliverables from CROs and vendors.
• Help establish internal standards and best practices within the biostatistics function.

Qualifications:

• PhD in Biostatistics, Statistics, or related field with 8+ years of industry experience; or MS with 11+ years; or BS with 13+ years.
• Experience with oncology trials strongly preferred.
• Proven track record supporting regulatory submissions (NDA/BLA).
• Expertise in CDISC standards (SDTM, ADaM) and statistical software (SAS, nQuery, EAST, Cytel Studio).
• Strong understanding of cross-functional drug development processes and regulatory guidelines.
• Excellent analytical, project management, and communication skills.

Additional Details:

• Location: This role is 100% onsite, Monday through Friday , at the King of Prussia, PA office.
• Relocation Assistance: Offered for qualified candidates.
• Visa Sponsorship: Available for eligible candidates.

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