Senior/Manager Programming Manager

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.

• Leads programming activities while providing hands-on support.
• 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 filing 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
• Has experience with the SAS software package
• Minimum BSc. or equivalent qualifications
• Has experience working in a global context
• Proficient in both written and spoken English

• Acts as a role model
• Leads programming study and/or compound team in an effective and professional manner
• Proactively engages in department activities
• Arranges lessons learned to share learnings
• Leads various initiatives within the department

• Acts as mentor for new employees or consultants

• Analytical and problem-solving skills
• Knowledge of the CDISC SDTM and ADaM data models
• 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 compromising quality

• Minimum BSc. or equivalent qualifications
• At least 2-5 years of experience within the pharmaceutical industry for Programming Manager, at least 6-8 years of experience for Senior Programming Manager
• Has experience working in a global context
• Proficient in both written and spoken English
• (Required) Proficient in writing SAS programs and macros to create analysis datasets and statistical summaries (tables, listings, and figures)
• (Preferred) Practical knowledge and experience using R to support clinical trial analyses.

• 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!