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 Programming Manager, Clinical Programming is responsible for ensuring integrity, consistency and adherence to Study Data Tabulation Model (SDTM) standards, perform sponsor oversight of relevant programming activities on the Biometrics vendor, ensure the quality and consistency of data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems. This role reports to the Director, Team Lead of Clinical Programming.

Responsibilities/tasks – including but not limited to:

• Implements and assists on developing company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis
• Ensures alignment 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
• Ensures study or portfolio-level SDTM datasets are in compliance with CDISC 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
• Ensures work carried out in accordance with applicable SOP’s and working practices, as well as global agency regulations/guidance’s
• Supports developing and reviewing standard processes and templates
• 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 externally consumers
• Produce other in-house checks of data consistencies
• Contributes to knowledge sharing, skill building and good collaboration with stakeholders and colleagues
• Contributes to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
• Maintains up-to-date knowledge on relevant regulatory guidelines/requirements
• Maintains a good working relationship with stakeholders and colleagues
• Participates and represent clinical programming in teams and meetings

Requirements:

• Bachelor’s degree in Statistics, Computer Science, Life Sciences. Master’s degree in Statistics, Computer Science, Life Sciences preferred
• Has experience working in a global context
• Proficient in both written and spoken English
• At least 3-5 years of experience within the pharmaceutical industry
• Has experience with the SAS software package

As Programming Manager, Clinical Programming, it is expected that the employee:

• Acts as a role model
• Leads programming study team in an effective and professional manner
• Proactively engages in department activities
• Arranges lessons learned to share learnings
• Leads various initiatives within the department
• Proactively contributes to support a global organization
• Acts as mentor for new employees or consultants

Competences and skills:

• SAS programming
• Analytical and problem-solving skills
• Expert knowledge of the CDISC SDTM data model: the corresponding structures and organizations of the data.
• Contextual understanding of the data
• Writes efficient, easily maintained and well documented computer programs
• Is systematic and organized in writing and archiving computer programs
• Proactive and Accountable and Goal oriented
• Innovative
• Good team player
• Good at sharing knowledge
• Works independently, take responsibility and show initiative
• Good communication skills
• Good planning and coordinating skills
• Ability to flexibly work on multiple tasks without compromise of the quality of the work

For US based candidates, the proposed salary band for this position is as follows:

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 bonuses.

Regular full-time U.S. employees are eligible to enroll in Genmab benefits. Our benefits package is crafted to help employees feel supported and cared for in all aspects of life — physical, financial, social, and emotional.

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing, dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab 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.