Senior Biostatistics Lead — Clinical Trial Strategy

Genmab; Princeton (NJ); Hybrid; USD 146,640 - 219,960; Full time

Benefits offered by this job

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

Health Benefits: medical plans, dental, vision

Paid vacation and sick leave

Tuition reimbursement

Commuter benefits

Job summary

A global biotechnology company in Princeton is looking for an Associate Director in Biostats to act as a key point of contact for statistical input on compounds. You'll lead statistical strategies for clinical trials, work closely with cross-functional teams, and engage with regulatory authorities. The ideal candidate has a Master's or PhD in a statistical field with at least 8 years of experience in drug development, particularly in complex statistical designs. This role offers a competitive salary package and comprehensive benefits including a generous 401(k) plan.

Qualifications

• 8+ years of experience in relevant area preferred, or demonstrated capability.
• Proven performance in earlier role/comparable role.
• Experience working with FDA, EMA, and ICH guidance.

Responsibilities

• Act as lead and main point of contact related to Statistics for designated compound.
• Ensure all work is shared between biostatisticians and with the vendor.
• Drive design and synopsis development together with relevant stakeholders.

Skills

Statistical analysis

Modelling and simulation

Adaptive trial designs

Education

Master's or PhD in a statistical discipline

Tools

SDTM

ADaM

eSUB and CDISC requirements

Job description

A global biotechnology company in Princeton is looking for an Associate Director in Biostats to act as a key point of contact for statistical input on compounds. You'll lead statistical strategies for clinical trials, work closely with cross-functional teams, and engage with regulatory authorities. The ideal candidate has a Master's or PhD in a statistical field with at least 8 years of experience in drug development, particularly in complex statistical designs. This role offers a competitive salary package and comprehensive benefits including a generous 401(k) plan.