Associate Director, Biostatistics

8+ years

$145,440.00---$218,160.00

Netherlands Remote, USA

10 Feb. 18, 2025

Job Description

Job Type: Full Time Education: M.Sc./M.Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, Biostatistics
Location: United States (Remote), New Jersey, United States of America
Category: Development Operations
Job Id: R11294

About Genmab

At Genmab, we're committed to developing antibody products and therapies that change lives and the future of cancer treatment. Our team is driven by a culture of care, candidness, and impact, believing in the power of being uniquely determined, innovative, and authentic to fulfill our purpose.

The Role

The Associate Director will act as a statistical expert in the clinical development of compounds, supporting early and late-stage programs. As a compound and/or indication lead, the Associate Director will contribute to clinical development strategies and plans.

Responsibilities

Compound/Indication Level

Serve as the lead and main point of contact for statistics related to the designated compound/indication.
Advise on new statistical methodologies that improve efficiencies and support innovation in drug development.
Engage with regulatory authorities for compound/indication-level discussions.
Ensure statistical consistency and data handling across trials.
Coordinate statistical input across biostatisticians and vendors.

Trial Level

Represent Genmab at key meetings, conferences, and during professional networking.
Collaborate with regulatory authorities on trial-level discussions.
Oversee biostatistical work to ensure high-quality documentation, QC, and adherence to SOPs and standards.

CTT Member

Participate in protocol development and ensure statistical input for clinical trials.
Collaborate in vendor oversight and exploratory analysis of trial data.
Support timely delivery of statistical deliverables and trial result meetings.

Collaboration with Global Drug Safety

Review and approve data packages for Data Monitoring Committees.
Support trial-related amendments and corrections.

Experience and Qualifications

Master's or PhD in a statistical discipline with 8+ years of experience in biostatistics.
Experience in statistical analysis, modeling, simulation, and adaptive trial designs.
Knowledge of FDA, EMA, ICH, and regulatory submissions for biostatistics processes.
Proven leadership in managing multiple complex projects.
Previous experience with SDTM, ADaM, and CDISC for regulatory submissions.

About You

You are passionate about transforming lives through innovative cancer treatment.
You bring rigor and excellence to everything you do.
You are a collaborative team player with a passion for learning and innovation.
You thrive in a dynamic, fast-growing company and embrace challenges with enthusiasm.

Locations

Genmab leverages an agile working environment for work-life balance, with community-based office spaces and remote work options.

Salary Range

$145,440.00—$218,160.00, based on experience, qualifications, and location.

Genmab's Commitment to Diversity, Equity, and Inclusion

We are committed to fostering workplace diversity at all levels and ensuring a fair, inclusive, and respectful work environment.

For further details, please visit Genmab’s Job Applicant Privacy Notice on their website.

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