Global Biostatistics Lead, Clinical Development

Jobtome; Princeton (NJ); Sur place; USD 157 000 - 235 000; Plein temps

Avantages offerts par ce poste

401(k) Plan: 100% match on first 6%

Health Benefits: Medical, dental, and视

Voluntary Plans: Critical illness, etc

Paid vacation, sick leave, holidays, 2

Résumé du poste

Genmab is seeking an Associate Director to act as statistical expert supporting clinical development at compound/indication level and trial level. You will lead statistical strategy, design trials, and engage with regulatory authorities to drive innovation and ensure rigorous analyses.

The role requires senior biostatistics experience, strong collaboration with programmers and data managers, and an ability to communicate complex methods to cross-functional partners while ensuring regulatory

Qualifications

• Master's or PhD in statistics or a related field.
• 8+ years of experience in biostatistics or clinical statistics.
• Experience with regulatory submissions and guidance documents.
• Proven ability to lead statistical work across trials and programs.

Responsabilités

• Act as lead and main point of contact related to Statistics for designated compound/indication.
• Provide statistical input to trial design, endpoints, analyses, and reporting.
• Engage with regulatory authorities on compound/indication level discussions.
• Coordinate data transfers and ensure state-of-the-art statistical work.
• Oversee integrated database development and planning for analyses.
• Represent Biostatistics in strategy discussions and regulatory meetings.
• Ensure documentation and data handling are compliant with ICH-GCP.

Connaissances

Statistical analysis

Modelling & simulation

Adaptive trial designs

Biostatistics in drug development

Regulatory interactions

Formation

Master's or PhD in statistics

Outils

SDTM

ADaM

CDISC

eSUB

Description du poste

Genmab is seeking an Associate Director to act as statistical expert supporting clinical development at compound/indication level and trial level. You will lead statistical strategy, design trials, and engage with regulatory authorities to drive innovation and ensure rigorous analyses.

The role requires senior biostatistics experience, strong collaboration with programmers and data managers, and an ability to communicate complex methods to cross-functional partners while ensuring regulatory