Senior Programming Associate / Programming Manager (...

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Role & Department As a Senior Programming Associate or Programming Manager, you will be in 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 be responsible for ensuring integrity, consistency, and adherence to standards, and ensuring 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. Position level for this position to a specific candidate is at the discretion of the Director, Programming. 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 for doing the same. Performs database consistency checks on databases delivered by vendor. Performs sponsor oversight of programming activities performed by vendor. Supports in-house production of tables, figures, and listings by writing programming code following good programming practices. Supports in-house QC process by applying the appropriate measures (writing of code, review of code/deliverable). 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 relationship with stakeholders and colleagues. Participates and represents programming function in teams and meetings. Develops, maintains, and ensures proper documentation is available and properly stored (e.g., in eTMF) for programming activities. 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. 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. As Programmer, it is expected that the employee: Acts as a role model Proactively engages in department activities Shares learnings with others Contributes to various initiatives within the department Proactively contributes to support a global organization Required competences and skills: SAS programming Analytical and problem-solving skills Knowledge of the CDISC, SDTM and ADaM data models: 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 as well as other documentation Thorough Proactive , accountable, and goal oriented Innovative Team player Good at sharing knowledge Takes responsibility and shows initiative Good communication skills Good planning and coordination skills Ability to flexibly work on multiple tasks without compromise of the quality of the work Where 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. For US based candidates, the proposed salary band for this position is as follows: $95,625.00---$159,375.00 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 bonuses. About You You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving You are a generous... Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

Created: 2024-11-05