Programming Manager, Clinical Programming

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 RoleWork arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.Responsibilities/tasks–includingbutnotlimitedto:Implementsandassistson developingcompanyStudy Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality,consistencyand compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, andanalysisEnsuresalignment of SDTM standards with data collection standards and relevant company tools/system requirements by reviewing study eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidanceEnsuresstudy or portfolio-level SDTM datasetsare in compliance withCDISC and regulatory submission requirements, reviews study submission data packages to ensure quality andintegrityCreates quality control processes,metricsand other measures to ensure compliance withstandardsEnsureswork carried outin accordance withapplicable SOP’s and working practices, as well as global agency regulations/guidance’sSupportsdevelopingandreviewingstandardprocessesandtemplates.Working with Digital Solutions and IT, support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externallyconsumersSupports development ofGenSenseDashboards by providing guidance on datastructure,organizationand contents of the Genmab SDTM-databases to the Dashboard developersand programmersProduce other in-house checks of dataconsistenciesContributes to knowledge sharing, skill building and good collaborationwith stakeholdersandcolleaguesContributes to ongoing improvements in cross-functional and global collaborationandsharing ofbetter practicesandknowledgeMaintainsup-to-dateknowledgeonrelevantregulatoryguidelines/requirementsMaintainsagoodworkingrelationshipwithstakeholdersandcolleaguesParticipatesandrepresentclinicalprogramminginteamsandmeetingsRequirements:Bachelor’s degree in Statistics, Computer Science, LifeSciences. Master’s degree in Statistics, Computer Science, Life SciencespreferredHasexperienceworkinginaglobalcontextProficient in both written and spokenEnglishAtleast3-5yearsofexperiencewithinthepharmaceuticalindustryHasexperiencewiththeSASsoftwarepackageAsProgrammingManager, Clinical Programming,itisexpectedthattheemployee:ActsasarolemodelLeadsprogrammingstudyteaminaneffectiveandprofessionalmannerProactivelyengagesindepartmentactivitiesArrangeslessonslearnedtosharelearningsLeadsvariousinitiativeswithinthedepartment · Proactivelycontributestosupportaglobal organizationActsasmentorfornewemployeesorconsultantsCompetencesandskills:SASprogrammingAnalyticalandproblem-solvingskillsExpert knowledge of the CDISC SDTM data model: the corresponding structures and organizations of the data.Contextual understandingofthedataWritesefficient,easilymaintainedandwelldocumentedcomputerprogramsIssystematicandorganizedinwritingandarchivingcomputerprogramsProactiveandAccountableandGoal orientedInnovativeGoodteamplayerGoodatsharingknowledgeWorksindependently,takeresponsibilityandshowinitiativeGoodcommunicationskillsGoodplanningandcoordinatingskillsAbility to flexibly work on multiple tasks without compromise of the quality of the workFor US based candidates, the proposed salary band for this position is as follows:$117,840.00---$176,760.00The 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: R17362Profession: Development Operations