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Associate Director, Biostatistics

8+ years
$145,440.00---$218,160.00
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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