Director, Biostatistics
ClinChoice
full-time
Posted on:
Location Type: Hybrid
Location: Princeton • New Jersey • United States
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Job Level
About the role
- Provide statistical leadership across one or more clinical programs, including study design, analysis strategy, and interpretation of results
- Lead the development and review of statistical deliverables, including protocols, SAPs, TFLs, ISS/ISE, and regulatory submission materials
- Serve as a key statistical representative in cross-functional team discussions and governance meetings
- Ensure statistical approaches comply with regulatory standards and industry best practices
- Provide guidance and oversight to internal and/or external biostatistics resources
- Support interactions with regulatory agencies as needed
- Contribute to strategic planning and decision-making at the program or portfolio level
Requirements
- PhD in Statistics, Biostatistics, or a related field
- 5+ years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry
- Strong experience supporting clinical trials across one or more phases
- Excellent communication skills, with the ability to clearly explain statistical concepts to non-statistical stakeholders
- Experience in CNS (Central Nervous System) therapeutic area is a strong plus
- Demonstrated ability to work effectively in a collaborative, cross-functional environment.
Benefits
- Health insurance
- Professional development opportunities
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical leadershipstudy designanalysis strategystatistical deliverablesprotocolsSAPsTFLsISSISEregulatory submission materials
Soft skills
excellent communication skillscollaborativecross-functional teamworkguidanceoversight
Certifications
PhD in StatisticsPhD in Biostatistics