Senior Programming Associate / Programming Manager (Remote or Hybrid)

Senior Programming Associate / Programming Manager (Remote or Hybrid)About GenmabGenmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates. 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.The Role & DepartmentAs a Senior Programming Associate or Programming Manager, you will be part of the Statistical Programming team and Development Operations organization, responsible for supporting the development of new therapies by performing programming tasks and/or leading a small team to complete various programming efforts within a clinical trial.You will ensure integrity, consistency, and adherence to standards, and provide well-structured, high-quality data summaries for internal decision-making and reporting to health authorities. You will report to the Director, Programming, and work closely with Data Management, Clinical Programming, Statistics, Medical Writing, and other functions as necessary.Key Responsibilities Include:Supports and/or leads programming efforts within a clinical study, depending on background and experience.As a lead, reviews CRFs for adequacy and consistency.Supports the establishment and maintenance of Genmab SDTM and ADaM database standards.As a lead, co-develops analysis-related derivation rules, develops data specifications for individual trials, and provides guidance to internal programmers or vendors.Performs database consistency checks on databases delivered by vendors.Performs sponsor oversight of programming activities performed by vendors.Supports in-house production of tables, figures, and listings by writing programming code following good programming practices.Supports in-house QC process by applying appropriate measures (writing code, review of code/deliverables).Supports submissions by ensuring programming deliverables are consistent with current agency standards and guidelines.Supports resource planning and outsourcing of programming activities.Supports developing and reviewing standard processes and templates.Supports process improvements within the programming department.Contributes to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge.Maintains up-to-date knowledge and competencies within relevant therapeutic and professional areas.Maintains up-to-date knowledge on relevant regulatory guidelines/requirements.Proactively develops and maintains good working relationships with stakeholders and colleagues.Participates and represents the programming function in teams and meetings.Develops, maintains, and ensures proper documentation is available and properly stored for programming activities.Supports development of GenSense Dashboards by providing guidance on data structure, organization, and contents of the Genmab SDTM-databases.Requirements - What You Must Have:Completed Bachelor of Science degree required or equivalent qualifications (e.g., programming experience and skills in the pharmaceutical industry).At least 3 years of direct experience in programming in the pharmaceutical industry.Knowledge, experience, and technical proficiency in the SAS software package.Experience working in a global context.Proficient in both written and spoken English.Oncology experience a plus.Programming in R or Python a plus.Required Competences and Skills:SAS programmingAnalytical and problem-solving skillsKnowledge of the CDISC, SDTM and ADaM data modelsContextual understanding of the dataWrites efficient, easily maintained, and well-documented computer programsSystematic and organized in writing and archiving computer programs and other documentationThorough, proactive, accountable, and goal-orientedInnovative and a team playerGood at sharing knowledgeTakes responsibility and shows initiativeGood communication skillsGood planning and coordination skillsAbility to flexibly work on multiple tasks without compromising qualityWhere You Will Work:This role is in Princeton, NJ USA and can be hybrid for candidates within commuting distance to the office.Candidates who must be remote (not within commuting distance to Genmab offices) and with home bases in the Eastern or Central Time Zones in the US will be considered.Salary:The proposed salary band for this position is $95,625.00 - $159,375.00. The actual salary offer will consider a wide range of factors, including your skills, qualifications, experience, and location. Certain positions are eligible for additional forms of compensation, such as bonuses.Our Commitment to Diversity, Equity, and Inclusion:We are committed to fostering workplace diversity at all levels of the company. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex, national origin, age, disability, or genetic information.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.

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