Director Biostatistics in Princeton, New Jersey, United States of America | Development Operations at Genmab

Director Biostatistics in Princeton, New Jersey, United States of America | Development Operations at Genmab Skip to main content Skip to main content Healthcare Professionals Patients & Care Partners Partnerships Contact Working at Genmab Career Areas Application Process Locations Talent Community Job Search Corporate Sign in Close the popup Sign in to Phenom Careers Enjoy a personalized jobs search Sign in with Google Employee Login Sign in with Google Sign up Saved jobs (0) Healthcare Professionals Patients & Care Partners Partnerships Contact Saved jobs (0) Toggle navigation - - Recruitment Fraud Warning: Please note that Genmab never requests payment, banking details, or Social Security numbers during the recruitment process. All legitimate job opportunities are listed exclusively on our Careers page at https://careers.genmab.com. If you receive suspicious communications claiming to be from Genmab, please report them to recruitingfraud@genmab.com immediately. 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Close Covid-19 banner Director Biostatistics Category Development Operations Job Id R17259 Remote This job available in 3 locations Princeton, New Jersey, United States of America Copenhagen, Capital, Denmark Utrecht, Netherlands Save Apply Now We are extra[not]ordinary*(ex· tra· not· or· di· nary |\ ik- str-not- r-d - ner- ) Adjective: A unique word for Genmab meaning to go way beyond what is usual; to be remarkable; proudly unique and authentic Back to search results Previous job Next job JOB DESCRIPTION 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 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