Director Biostatistics

At Genmab, we are dedicated to building extra(not)ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.Does this inspire you and feel like a fit? Then we would love to have you join us!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 LevelAct as lead and main point of contact related to Statistics for designated compound/indicationFollow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authoritieson compound/indication level discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendorSupports compound responsible programmer in developing an integrated database specificationCDT member:Responsible for giving statistical input to overall strategy and the synopsis development in the CDTProvide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicableDrive design and synopsis development together with relevant stakeholdersEnsure transparent communication to relevant stakeholders from the CDTEnsure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needsSupport development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articlesTrial LevelRepresent Genmab during meetings/congresses and courses and perform professional networkingEngage with regulatory authoritieson trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab during Key Opinion Leaders meetingsEnsure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicableEnsures state of the art statistical work which includes but is not limited to:Applying adequate methods for which a solid scientific foundation existsEnsure proper documentation of work doneKeep oversight and QC essential documents/data provided by vendorsEnsure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCPCTT member:Participate and represent BiostatisticsReview and provide input to protocol and amendment developmentPerform vendor oversight according to applicable SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.Review assay validation reports, as applicablePerform exploratory analysis, ad hoc analyses, and modelling of dataReview and approve randomization and stratification plansPerform UAT of Randomization part of the IRT system as applicableEnsure procedures for blinding are in place as applicableSupport timely delivery of statistical deliverablesResponsible for planning and conducting trial result meetingsReview and approve the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review, and approval of data packages for Data Monitoring CommitteesReview and approve any amendments, corrections, and updates of data packagesCRO selection and collaborationPerform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasksReview 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 applicableSupport regulatory submission/filing activitiesExperience:Master's or PhD in a statistical discipline12+ years of experience in relevant area preferred, or demonstrated capabilityExperience in statistical analysis, modelling and simulation and adaptive trial designsExperience with drug development in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA, EMA, and ICH guidance for drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategiesExperience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissionsExperience directing multiple complex projects/studies in a technical capacityExperience leading and mentoring teamsProven performance in earlier role/comparable roleFor US based candidates, the proposed salary band for this position is as follows:$203,440.00---$305,160.00The 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 contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans: Critical illness, accident, and hospital indemnity insuranceTime Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expensesFurther details on eligibility for compensation and benefits based on role will be provided during the recruitment processAbout GenmabGenmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.Job SummaryJob number: R17259Date posted : Profession: Development OperationsEmployment type: Full time