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 with responsibilities as described below. The Director contributes to clinical development strategies and plans.
Responsibilities:Compound/Indication Level
- 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
For US based candidates, the proposed salary band for this position is as follows:
$203,440.00---$305,160.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
- 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
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
