Associate Director, Biostatistics

Scorpion Therapeutics; Needham (MA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

NDA/BLA submissions experience

Job summary

Scorpion Therapeutics is seeking a senior statistics leader to drive clinical development programs from study design through regulatory submission. You will collaborate with cross-functional teams to ensure robust statistical analysis and regulatory readiness.

Responsibilities include leading protocol and SAP development, data analysis and interpretation, overseeing CRO deliverables, and contributing to internal statistical standards and team development.

Qualifications

• PhD or MS in Biostatistics or related field.
• 5+ years (PhD) or 8+ years (MS) industry experience.
• Expertise in clinical trial design, statistical methodology, regulatory principles, and SAS proficiency.
• Strong communication skills.
• Ability to manage multiple projects independently.

Responsibilities

• Lead statistical activities including protocol and SAP development, data analysis, interpretation, and support for regulatory interactions
• Oversee CRO deliverables
• Contribute to statistical standards and team development

Skills

Clinical trial design

Statistical methodology

Regulatory principles

SAS

Education

PhD or MS in Biostatistics or related field

Tools

SAS

Job description

Role

Provide statistical leadership for clinical development programs from study design to regulatory submission, acting as a key partner to cross-functional teams.

Responsibilities

• lead statistical activities including protocol and SAP development, data analysis, interpretation, and support for regulatory interactions
• oversee CRO deliverables
• contribute to statistical standards and team development

Requirements

• PhD or MS in Biostatistics or related field
• 5+ years (PhD) or 8+ years (MS) industry experience
• expertise in clinical trial design, statistical methodology, regulatory principles, and proficiency with SAS
• strong communication skills
• ability to manage multiple projects independently

HighValue

experience with NDA/BLA submissions, clinical trials in biotech/pharma settings, and hands-on statistical analysis.

WorkSetup

not specified.