Associate Director, Biostatistics | Multiple Locations
Job ID: R13924
Category: Development Operations
Location: Multiple Locations (U.S. & International)
Job Type: Full-Time
About Genmab
Genmab is a global biotechnology company dedicated to developing innovative antibody therapeutics that transform the lives of patients with cancer and other serious diseases. With over 25 years of experience, Genmab has created next-generation antibody platforms, including bispecific T-cell engagers, antibody-drug conjugates, and immune checkpoint modulators.
Headquartered in Copenhagen, Denmark, Genmab operates internationally across North America, Europe, and Asia-Pacific, fostering a culture of innovation, collaboration, and scientific excellence.
Learn more at www.genmab.com.
Role Overview
The Associate Director, Biostatistics is a senior-level statistical expert responsible for supporting clinical development programs. This role may act as compound or indication lead and/or as trial responsible statistician for early- and late-stage programs.
The Associate Director contributes to clinical development strategy, statistical planning, and regulatory interactions, ensuring robust, scientifically sound methodologies across trials and compounds.
Key Responsibilities
Compound / Indication Leadership
Serve as primary statistical lead for assigned compounds or indications.
Advise on innovative statistical methodologies to enhance efficiency and trial design.
Engage with regulatory authorities at the compound/indication level.
Ensure consistency of statistical methods and data handling across trials.
Coordinate with programming and vendor teams to support integrated database development.
Clinical Development Team (CDT) Support
Provide statistical input on trial design, synopsis development, and advanced methodologies.
Represent Genmab at regulatory meetings, Key Opinion Leader (KOL) events, and partner discussions.
Drive statistical strategy, synopsis development, and communication of findings.
Support integrated analysis and regulatory submission requirements.
Trial-Level Responsibilities
Review and approve protocols, statistical analysis plans, clinical study reports (CSR), and results presentations.
Ensure application of state-of-the-art statistical methods and proper documentation.
Oversee vendor work and ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
Coordinate with global drug safety teams on Data Monitoring Committees and regulatory submissions.
Collaboration & Professional Networking
Represent Genmab at scientific meetings, congresses, and training courses.
Mentor and guide biostatisticians and cross-functional teams in trial execution and methodology.
Required Qualifications
Master’s or PhD in Statistics, Biostatistics, or related discipline.
8+ years of biostatistics experience in drug development.
Expertise in statistical analysis, modeling, simulation, and adaptive trial design.
Experience in biologics, targeted therapies, or companion diagnostics preferred.
Knowledge of FDA, EMA, and ICH guidance for clinical development.
Familiarity with CDISC standards (SDTM, ADaM), eSUB, and regulatory submissions.
Proven track record in leading complex clinical projects and multi-disciplinary teams.
Compensation & Benefits (U.S.)
Salary Range: $145,440 – $218,160 annually (based on skills, experience, and location)
Benefits Include:
401(k) Plan: 100% match on the first 6% of contributions.
Health Coverage: Medical, dental, vision, and HSA options.
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary parental leave.
Wellness & Lifestyle: Access to backup care, wellness programs, tuition reimbursement, and a Lifestyle Spending Account.
Additional Perks: Commuter benefits, voluntary insurance plans, and long-term incentive eligibility.
About You
Passionate about biostatistics and clinical research excellence.
Collaborative, innovative, and committed to high-quality scientific outcomes.
Comfortable navigating complex projects, regulatory frameworks, and multi-disciplinary teams.
Dedicated to fostering team development and mentorship.
Enjoys contributing to a dynamic, growth-oriented biotech environment.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Donegal |Meath :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Argentina | Peru |Brazil :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Green Way | Remote - Europe | Ireland | Thailand | Castlebar | Remote - Middle East | Texas | Nairobi | Bountiful | French | Zaragoza | Belgium | Lousiana | Manipal | Remote - Africa | Lenexa | McFarland | Remote - South America (Latin Americal) | Tulsa | Victoria | Hungary | Medan | Blue Bell | Remote | Leinster | Faridabad | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Springville | Riga | Hammond | Remote, USA | Slovakia | Switzerland | Melbourne | Xzagreb | Minnesota |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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