The Statistical Manager supports the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence for Clinical Research & Development and Medical Affairs programs with minimal supervision. This position supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents the Clinical Biostatistics function for cross-functional and intra-departmental teams or working groups.

Specifically, the Statistical Manager will function as project statistician for the assigned clinical trials, primarily up until proof of concept, and/or as trial responsible statistician with responsibilities as described below and represent Biostatistics in a multidisciplinary trial team responsible for the execution of the trial (including supervision of biometrical activities performed by CROs), and be accountable for assigned biostatistics deliverables within the responsible areas. Hence, the Statistical Manager should have advanced data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support, is effective in the use of relevant computational tools for study, experiment, or trial research objectives, and applies high quality statistical methodology when working on projects with good understanding of the disease/scientific/functional area and health authority acceptability.

Responsibilities

• Develops and maintains advanced competences in statistical analysis, modelling and simulation and advanced trial designs
• Ensure that clinical trials meet scientific, regulatory, and quality requirements
• Participate in-house and/or outsourced biostatistical activities
• Perform trial statistician responsibilities, including attendance of clinical team meetings, authoring Statistical Analysis Plans, reviewing Case Report Foms, designing of clinical trials of all phases (including clinical pharmacology studies), review of protocols/amendments, conducting statistical analyses, and performing just-in-time analyses, etc.
• Apply innovative statistical approaches to study design, analysis and data exploration methodologies
• Participate and track study level activities, especially biometrics-related ones; ensure development timelines and objectives are met.
• May represent the company as a statistical subject matter expert in regulatory interactions and other external meetings for trial related and/or compound/indication related discussions
• Ensures consistency of statistical methods and data handling across trials
• Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
• Supports compound responsible programmer in developing an integrated database specification
• Contribute to clinical development plans
• Arrange/attend lessons learned to share learnings
• Represent Genmab during external meetings/congresses
• Proactively engage in department activities
• Actively participate various initiatives within the department
• Proactively contribute to building a global Genmab organization
• May act as mentor for new employees or consultants

Requirements

• In-depth understanding of statistical issues in oncology drug development
• At least 2-4 years of industry experience in statistics within a clinically related subject
• Experience with oncology clinical trials
• Proficient programming skills in statistical software’s, such as SAS
• Excellent oral and written communication skills
• Ability to work independently as well as in teams
• Confident, self-reliant, and a quick learner
• Proactive and open minded
• Ability to prioritize and work in a fast-paced and changing environment
• Result and goal-oriented and committed to contributing to the overall success of Genmab

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.