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.

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

Supports development of GenSense 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 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:

$117,840.00 176,760.00

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 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 contributions

Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance

Voluntary Plans: Critical illness, accident, and hospital indemnity insurance

Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave

Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support

Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process

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.

Full Time