Associate Director, Biostatistics

At Genmab we are dedicated to building extranotordinary futures together by developing antibody products and groundbreaking knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create champion and maintain a global workplace where individuals unique contributions are valued and drive innovative solutions to meet the needs of our patients care partners families and employees.

Our people are compassionate candid and purposeful and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes our work is incredibly serious and impactful but we have big ambitions bring a ton of care to pursuing them and have a lot of fun while doing so.

Does this inspire you and feel like a fit Then we would love to have you join us!

The Role
The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs and/or as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.

Responsibilities:

Compound/Indication Level

• Act as lead and main point of contact related to Statistics for designated compound/indication
• Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
• Engage with regulatory authoritieson compound/indication level discussions
• Acts as a role model
• 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

CDT member:

• Responsible for giving statistical input to overall strategy and the synopsis development in the CDT
• Provide scientific advice to the CDT including design of trials analyses and analyses requiring advanced statistical methodologies/techniques
• Represent the CDT/the company at regulatory meetings during Key Opinion Leaders meetings network and/or Partner meetings as applicable
• Drive design and synopsis development together with relevant stakeholders
• Ensure transparent communication to relevant stakeholders from the CDT
• Ensure availability of integrated database(s) as needed and planning and conduct of integrated analysis to support development decisions submissions and marketing needs
• Support development and communication in relation to communication strategy and/or scientific input to presentations posters and articles

Trial Level

• Represent Genmab during meetings/congresses and courses and perform professional networking
• Engage with regulatory authoritieson trial level discussions
• Arranges/attends lessons learned to share learnings
• Represents Genmab during Key Opinion Leaders meetings
• Ensure biostatistician review of partner synopsis protocols statistical analysis plans results meetings presentations and clinical trial reports
• Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager as applicable
• Ensures state of the art statistical work which includes but is not limited to:
• Applying adequate methods for which a solid scientific foundation exists
• Ensure proper documentation of work done
• Keep oversight and QC essential documents/data provided by vendors
• Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP

CTT member:

• Participate and represent Biostatistics
• Review and provide input to protocol and amendment development
• Perform vendor oversight according to applicable SOPs
• Give input to eCRF setup edit checks validation plan protocol deviations classifications DSUR IB updates tables figures and listings etc.
• Review assay validation reports as applicable
• Perform exploratory analysis ad hoc analyses and modelling of data
• Review and approve randomization and stratification plans
• Perform UAT of Randomization part of the IRT system as applicable
• Ensure procedures for blinding are in place as applicable
• Support timely delivery of statistical deliverables
• Responsible for planning and conducting trial result meetings
• Review and approve the CSR
• Attend trial and investigator meetings if/as needed
• Collaboration with Genmab Global Drug Safety:
• Participate in definition review and approval of data packages for Data Monitoring Committees
• Review and approve any amendments corrections and updates of data packages
• Support regulatory submission/filing activities

Requirements:

• Masters or PhD in a statistical disciplinewith 8 of experience in relevant technical area
• Experience in statistical analysis modelling and simulation and adaptive trial designs
• Experience with drug development in biologics targeted therapies and companion diagnostics preferred
• Experience working with FDA EMA and ICH guidance for drug development pertaining to statistics
• Experience with the relevant regulatory requirements for biostatistics processes and SOPs
• Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
• Experience working with SDTM ADaM eSUB and CDISC requirements for regulatory submissions
• Experience directing multiple complex projects/studies in a technical capacity
• Proven performance in earlier role/comparable role

For US based candidates the proposed salary band for this position is as follows:

$$219160

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 and long-term incentives.

When you join Genmab youre 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 paid parental leave
• Support Resources: Access to child and adult backup care fertility and family-building 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

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can 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 maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our 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 to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs 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 international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs 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.