Manager, 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 Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for decision making.

Responsibilities in leading the programming efforts of at least one study are in scope.

The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above by developing and writing corresponding SAS or other programs.

Responsibilities/tasks – including but not limited to:

• Reviews CRFs for adequacy and consistency
• Supports the establishment and maintenance of Genmab SDTM and ADaM database standards
• Performs database standards consistency checks on databases delivered by the preferred DM & Statistics vendor to Genmab
• Produces other in-house checks of data consistencies
• Supports specification and pooling of data across clinical trials within the same project
• Supports in-house production of analysis datasets, tables, figures and listings, by writing the corresponding programs and ensuring QC before formal release, for the following non-comprehensive list of deliverables: IB, DSUR, briefing packages for FDA, EMA etc., supplementary in-house preparations for DMC-meetings, RP2D- selection preparations, supplementary material for interim analysis and final analyses (e.g. sub-group or other analyses not pre-defined in the SAP), answers to questions posed by regulatory authorities or ethics committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.
• Performs sponsor oversight of programming activities on the DM & Statistics vendor
• Performs QC on SAS-code written by other Genmab colleagues
• Supports submissions by ensuring that the programming-related part of the file is consistent with current electronic submission standards and guidelines.
• 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.
• Supports resource planning and outsourcing of programming activities.
• Supports developing and reviewing standard processes and templates.
• 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
• Contributes to process improvements
• Maintains up-to-date knowledge and competencies within relevant therapeutic and professional areas
• Maintains up-to-date knowledge on relevant regulatory guidelines/requirements
• Maintains a good working relationship with stakeholders and colleagues
• Participates and represent programming in teams and meetings

Requirements:

• Minimum BSc. or equivalent qualifications
• At least 2-5 years of experience within the pharmaceutical industry
• Has experience working in a global context
• Proficient in both written and spoken English
• Has experience with the SAS software package

Additional Job Description

• Assist with consistency checks against standards including checks on databases delivered by vendors, and provide sponsor oversight of vendor programming activities
• Execute assigned tasks for in-house production of analysis datasets, tables, figures and listings as well as specification and pooling of data across clinical trials within assigned projects
• Assist with QC on SAS-code written by other Genmab colleagues
• Execute activities related to development of GenSense Dashboards with some guidance on data structure, organization, and contents of the Genmab SDTM-databases
• Assist with optimization of programming processes, standards, and templates

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 .

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