Programming Manager, Clinical Programming

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