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 Manager, you will be in the Programming team, responsible for supporting the development of new therapies by performing programming tasks and leading a small team to complete programming activities within one or more clinical trials. 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.
Key responsibilities include:
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
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 the 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.
Leads 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
Requirements - what you must have
Completed Bachelor’s Degree required or equivalent qualifications (e.g., programming experience and skills in the pharmaceutical industry)
At least 8 years of direct experience in programming in the pharmaceutical industry
Experience leading a team of programmers to complete programming activities
Knowledge, experience, and technical proficiency in the SAS software package
Experience working in a global context
Proficient in both written and spoken English
Oncology and regulatory submission experience a plus
As Programmer, it is expected that the employee:
Acts as a role model
Proactively engages in department activities
Shares learnings with others
Leads and/or 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 will report to the Princeton, NJ USA office.
The Senior Manager may be hybrid or remote. Remote-based applicants in the US Eastern Time Zone are strongly preferred.
For US based candidates, the proposed salary band for this position is as follows:
$114,375.00---$190,625.00The 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 collaborator who can work in teams with diverse backgrounds
You are determined to do and be your best and take pride in enabling the best work of others on the team
You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 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, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
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 https://www.genmab.com/privacy.
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
