Director Biostatistics

Meet Life Sciences; United States; On-site; USD 200,000 - 350,000; Full time

Job summary

Meet Life Sciences seeks a Director of Biostatistics to oversee oncology clinical trials. The role demands strategic leadership in statistical methods, requiring a PhD and over ten years of industry experience. This position is located either onsite in the San Francisco Bay area or King of Prussia, with relocation support available.

Qualifications

• 10+ years experience in oncology clinical trials.
• Expertise in regulatory interactions with FDA/EU.
• Bachelor's or advanced degree in relevant field.

Responsibilities

• Lead statistical strategies for oncology trials.
• Oversee CROs to deliver quality outputs.
• Develop statistical analysis plans and trial designs.

Skills

Statistical strategy oversight

Regulatory submissions

Clinical trial management

CDISC standards knowledge

Data interpretation

CRO management

Education

PhD in Biostatistics or Statistics

Tools

SAS

EAST

nQuery

Job description

2 weeks ago Be among the first 25 applicants

Direct message the job poster from Meet Life Sciences

We are working closely with a global biotechnology company for a Director of Biostatistics to play a strategic leadership role within their oncology development organization. This individual will lead statistical strategy and oversight across global clinical trials spanning early- to late-stage development, with a strong focus on regulatory readiness, data integrity, and scientific excellence.

Director Biostatistics - On-site in San Francisco Bay OR King of Prussia is required (Relocation support provided)

Key Responsibilities

• Provide strategic direction and technical oversight for statistical aspects of oncology clinical trials (Phases I–IV)
• Lead the development of statistical analysis plans, trial designs, and data interpretation strategies
• Contribute to the development and validation of integrated safety and efficacy datasets (ISS/ISE)
• Serve as the statistical representative in interactions with health authorities, ethics committees, and internal governance boards
• Evaluate and manage CROs and other external vendors to ensure high-quality deliverables and compliance with timelines and budgets
• Support initiatives to standardize best practices, CDISC implementation, and innovative statistical approaches

Candidate Profile

• PhD in Biostatistics, Statistics, or related field and +10 years experience within industry
• Direct experience in oncology clinical trials with strong focus on late-stage development
• Expertise in regulatory submissions and interaction with FDA/EU health authorities
• Strong working knowledge of CDISC standards (SDTM, ADaM) and statistical tools (e.g., SAS, EAST, nQuery)
• Experience managing or closely overseeing CROs and external partners
• Confident communicator with the ability to present complex data to senior stakeholders and cross-functional leadership
• On-site in San Francisco Bay OR King of Prussia is required (Relocation support provided)

If you are interested please apply or reach out via [e-mail] !

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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