Manager, Programming

At Genmab we are dedicated to building extranotordinary 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. The Senior Programming Manager may also serve as a compound lead.

Responsibilities/tasks including but not limited to:

• 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

As Programming Manager it is expected that the employee:

• 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

Proactively contributes to support a global organization

• Acts as mentor for new employees or consultants

Competences and skills:

• 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

Requirements:

• 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.

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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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