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 Role

Work 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.

• Implementsandassistson developingcompany
  
  Study 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, and analysis
• Ensuresalignment 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 guidance
• Ensuresstudy or portfolio‑level SDTM datasetsare in compliance withCDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity
• Creates quality control processes,metrics and other measures to ensure compliance with standards
• Ensureswork carried outin accordance with applicable SOP’s and working practices, as well as global agency regulations/guidance’s
• Supportsdevelopingandreviewingstandardprocessesandtemplates.
• 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 externallyconsumers
• Supports development ofGen Sense Dashboards  by providing guidance on data structure,organization and contents of the Genmab SDTM‑databases to the Dashboard developers and programmers
• Produce other in‑house checks of dataconsistencies
• Contributes to knowledge sharing, skill building and good collaborationwithstakeholdersandcolleagues
• Contributes to ongoing improvements in cross‑functional and global collaborationandsharing ofbetter practicesandknowledge

• Maintainsup‑to‑dateknowledgeonrelevantregulatoryguidelines/requirements
• Maintainsagoodworkingrelationshipwithstakeholdersandcolleagues
• Participatesandrepresentclinicalprogramminginteamsandmeetings

Requirements:

• Bachelor’s degree in Statistics, Computer Science, Life Sciences. Master’s degree in Statistics, Computer Science, Life Sciencespreferred
• Hasexperienceworkinginaglobalcontext
• Proficient in both written and spokenEnglish
• Atleast3‑5yearsofexperiencewithinthepharmaceuticalindustry
• HasexperiencewiththeSASsoftwarepackage

As Programming Manager , Clinical Programming,itisexpectedthattheemployee:

• Actsasarolemodel
• Leadsprogrammingstudyteaminaneffectiveandprofessionalmanner
• Proactivelyengagesindepartmentactivities
• Arrangeslessonslearnedtosharelearnings
• Leadsvariousinitiativeswithinthedepartment

Proactivelycontributestosupportaglobal organization

• Actsasmentorfornewemployeesorconsultants

Competencesandskills:

• SASprogramming
• Analyticalandproblem‑solving skills
• Expert knowledge of the CDISC SDTM data model: the corresponding structures and organizations of the data.
• Contextual understandingofthedata
• Writesefficient,easilymaintainedandwelldocumentedcomputerprograms
• Issystema…