Director Biostatistics

Genmab; Utrecht; On-site; EUR 178,158 - 267,237; Full time

Benefits offered by this job

401(k) Plan

Health Benefits

Voluntary Plans

Time Off

Support Resources

Additional Perks

Job summary

Genmab is seeking a Director of Statistics to act as statistical expert supporting clinical development of compounds as lead statistician for both early and late-stage programs. The role drives strategy, design and analyses across trials and engages with regulators to ensure robust submissions.

You will lead biostatistics, mentor teams, coordinate with vendors and programmers, and ensure comprehensive statistical plans and integrated analyses for decision making and regulatory submissions.

Qualifications

• Master's or PhD in a statistical discipline.
• 12+ years of experience in statistics for drug development preferred.
• Experience with biostatistics in biologics and targeted therapies.
• FDA/EMA/ICH guidance experience.

Responsibilities

• Lead and contact for Statistics for designated compound/indication.
• Advise on new methodologies to support innovation and efficiency.
• Engage with regulatory authorities on compound/indication level discussions.
• Ensure state-of-the-art statistical work and proper documentation.
• Coordinate data transfers with vendors and programmers.
• Represent Genmab at meetings and conferences.

Skills

Biostatistics leadership

Statistical modelling

Regulatory submissions

FDA/EMA collaboration

Mentoring teams

Education

Master's or PhD in statistics

Tools

SDTM/ADaM/CDISC

Clinical trial data management

Regulatory knowledge

Job description

The Role

The Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician. The Director contributes to clinical development strategies and plans.

Responsibilities

• Act as lead and main point of contact related to Statistics for designated compound/indication
• Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
• Engage with regulatory authorities on compound/indication level discussions
• Acts as a role model
• Ensures consistency of statistical methods and data handling across trials
• Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
• Supports compound responsible programmer in developing an integrated database specification

CDT Member

• Responsible for giving statistical input to overall strategy and the synopsis development in the CDT
• Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
• Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
• Drive design and synopsis development together with relevant stakeholders
• Ensure transparent communication to relevant stakeholders from the CDT
• Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
• Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles

Trial Level

• Represent Genmab during meetings/congresses and courses and perform professional networking
• Engage with regulatory authorities on trial level discussions
• Arranges/attends lessons learned to share learnings
• Represents Genmab during Key Opinion Leaders meetings
• Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
• Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
• Ensures state of the art statistical work which includes but is not limited to:
• Applying adequate methods for which a solid scientific foundation exists
• Ensure proper documentation of work done
• Keep oversight and QC essential documents/data provided by vendors
• Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP

CTT Member

• Participate and represent Biostatistics
• Review and provide input to protocol and amendment development
• Perform vendor oversight according to applicable SOPs
• Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.
• Review assay validation reports, as applicable
• Perform exploratory analysis, ad hoc analyses, and modelling of data
• Review and approve randomization and stratification plans
• Perform UAT of Randomization part of the IRT system as applicable
• Ensure procedures for blinding are in place as applicable
• Support timely delivery of statistical deliverables
• Responsible for planning and conducting trial result meetings
• Review and approve the CSR
• Attend trial and investigator meetings if/as needed
• Collaboration with Genmab Global Drug Safety:
• Participate in definition, review, and approval of data packages for Data Monitoring Committees
• Review and approve any amendments, corrections, and updates of data packages
• CRO selection and collaboration
• Perform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasks
• Review scope of work (within own project) in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)
• Attend operational and steering committee meetings, as applicable
• Support regulatory submission/filing activities

Experience

• Master's or PhD in a statistical discipline
• 12+ years of experience in relevant area preferred, or demonstrated capability
• Experience in statistical analysis, modelling and simulation and adaptive trial designs
• Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred
• Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
• Experience with the relevant regulatory requirements for biostatistics processes and SOPs
• Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
• Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
• Experience directing multiple complex projects/studies in a technical capacity
• Experience leading and mentoring teams
• Proven performance in earlier role/comparable role

Salary (US)

$203,440.00 — $305,160.00

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well‑being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses