Genmab A/S
Overview
At Genmab, we are dedicated to building exceptional futures by developing antibody products and breakthrough medicines that change lives and advance cancer treatment and serious diseases. We strive to create a global workplace where individuals’ unique contributions are valued and drive innovative solutions for 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 authentically determined to do our best is essential to fulfilling our purpose. Our work is serious and impactful, but we have big ambitions, care deeply for pursuing them, and have fun along the way. Does this inspire you and feel like a fit? Then we would love to have you join us! 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 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 Compound/Indication Level: Follow scientific and technical progress within biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies Compound/Indication Level: Engage with regulatory authorities on compound/indication level discussions Compound/Indication Level: Acts as a role model Compound/Indication Level: Ensure consistency of statistical methods and data handling across trials Compound/Indication Level: Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor Compound/Indication Level: Support compound responsible programmer in developing an integrated database specification CDT member: Provide statistical input to overall strategy and the synopsis development in the CDT CDT member: Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques CDT member: Represent the CDT/the company at regulatory meetings, Key Opinion Leaders meetings, network and/or Partner meetings, as applicable CDT member: Drive design and synopsis development together with relevant stakeholders CDT member: Ensure transparent communication to relevant stakeholders from the CDT CDT member: Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs CDT member: 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 Trial Level: Engage with regulatory authorities on trial level discussions Trial Level: Arranges/attends lessons learned to share learnings Trial Level: Represents Genmab during Key Opinion Leaders meetings Trial Level: Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings, presentations and clinical trial reports Trial Level: Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable Trial Level: Ensure state of the art statistical work including applying adequate methods with a solid scientific foundation and proper documentation Trial Level: Keep oversight and QC essential documents/data provided by vendors Trial Level: Ensure trial related work is performed in accordance with Genmab SOPs/processes and standards and ICH-GCP CTT member: Participate and represent Biostatistics CTT member: Review and provide input to protocol and amendment development CTT member: Perform vendor oversight according to applicable SOPs CTT member: Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings CTT member: Review assay validation reports, as applicable CTT member: Perform exploratory analysis, ad hoc analyses, and modelling of data CTT member: Review and approve randomization and stratification plans CTT member: Perform UAT of Randomization part of the IRT system as applicable CTT member: Ensure procedures for blinding are in place as applicable CTT member: Support timely delivery of statistical deliverables CTT member: Responsible for planning and conducting trial result meetings CTT member: Review and approve the CSR CTT member: Attend trial and investigator meetings if/as needed CTT member: Collaboration with Genmab Global Drug Safety CTT member: Participate in definition, review, and approval of data packages for Data Monitoring Committees CTT member: Review and approve any amendments, corrections, and updates of data packages CTT member: Support regulatory submission/filing activities Experience
Master's or PhD in a statistical discipline 8+ years of experience in relevant area preferred, or demonstrated capability 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 BLA and discussions/ negotiations with Health authorities 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 Compensation
For US based candidates, the proposed salary band for this position is $145,440.00 — $218,160.00. The actual salary offer will consider a wide range of factors, including skills, qualifications, experience, and location. Some positions are eligible for discretionary bonuses and long-term incentives. Benefits and Onboarding
When you join Genmab, you’re 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 discretionary paid parental leave Support Resources: Access to child and adult backup care, family support 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 supports an agile working environment and open, community-based spaces that connect employees with our powerful laboratories. Whether you’re in an office or remote, we emphasize collaboration and innovation. About Genmab
Genmab is an international biotechnology company focused on improving patients’ lives through innovative antibody therapeutics. For 25 years, our team has developed next-generation antibody technology platforms and data-driven sciences, resulting in a pipeline including bispecific T-cell engagers, antibody-drug conjugates, immune checkpoint modulators, and function-enhanced antibodies. Our vision is to transform lives by 2030 with Knock-Your-Socks-Off (KYSO) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with an international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com. Follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application. Note: Netherlands hires may be offered fixed-term contracts initially.
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At Genmab, we are dedicated to building exceptional futures by developing antibody products and breakthrough medicines that change lives and advance cancer treatment and serious diseases. We strive to create a global workplace where individuals’ unique contributions are valued and drive innovative solutions for 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 authentically determined to do our best is essential to fulfilling our purpose. Our work is serious and impactful, but we have big ambitions, care deeply for pursuing them, and have fun along the way. Does this inspire you and feel like a fit? Then we would love to have you join us! 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 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 Compound/Indication Level: Follow scientific and technical progress within biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies Compound/Indication Level: Engage with regulatory authorities on compound/indication level discussions Compound/Indication Level: Acts as a role model Compound/Indication Level: Ensure consistency of statistical methods and data handling across trials Compound/Indication Level: Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor Compound/Indication Level: Support compound responsible programmer in developing an integrated database specification CDT member: Provide statistical input to overall strategy and the synopsis development in the CDT CDT member: Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques CDT member: Represent the CDT/the company at regulatory meetings, Key Opinion Leaders meetings, network and/or Partner meetings, as applicable CDT member: Drive design and synopsis development together with relevant stakeholders CDT member: Ensure transparent communication to relevant stakeholders from the CDT CDT member: Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs CDT member: 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 Trial Level: Engage with regulatory authorities on trial level discussions Trial Level: Arranges/attends lessons learned to share learnings Trial Level: Represents Genmab during Key Opinion Leaders meetings Trial Level: Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings, presentations and clinical trial reports Trial Level: Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable Trial Level: Ensure state of the art statistical work including applying adequate methods with a solid scientific foundation and proper documentation Trial Level: Keep oversight and QC essential documents/data provided by vendors Trial Level: Ensure trial related work is performed in accordance with Genmab SOPs/processes and standards and ICH-GCP CTT member: Participate and represent Biostatistics CTT member: Review and provide input to protocol and amendment development CTT member: Perform vendor oversight according to applicable SOPs CTT member: Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings CTT member: Review assay validation reports, as applicable CTT member: Perform exploratory analysis, ad hoc analyses, and modelling of data CTT member: Review and approve randomization and stratification plans CTT member: Perform UAT of Randomization part of the IRT system as applicable CTT member: Ensure procedures for blinding are in place as applicable CTT member: Support timely delivery of statistical deliverables CTT member: Responsible for planning and conducting trial result meetings CTT member: Review and approve the CSR CTT member: Attend trial and investigator meetings if/as needed CTT member: Collaboration with Genmab Global Drug Safety CTT member: Participate in definition, review, and approval of data packages for Data Monitoring Committees CTT member: Review and approve any amendments, corrections, and updates of data packages CTT member: Support regulatory submission/filing activities Experience
Master's or PhD in a statistical discipline 8+ years of experience in relevant area preferred, or demonstrated capability 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 BLA and discussions/ negotiations with Health authorities 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 Compensation
For US based candidates, the proposed salary band for this position is $145,440.00 — $218,160.00. The actual salary offer will consider a wide range of factors, including skills, qualifications, experience, and location. Some positions are eligible for discretionary bonuses and long-term incentives. Benefits and Onboarding
When you join Genmab, you’re 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 discretionary paid parental leave Support Resources: Access to child and adult backup care, family support 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 supports an agile working environment and open, community-based spaces that connect employees with our powerful laboratories. Whether you’re in an office or remote, we emphasize collaboration and innovation. About Genmab
Genmab is an international biotechnology company focused on improving patients’ lives through innovative antibody therapeutics. For 25 years, our team has developed next-generation antibody technology platforms and data-driven sciences, resulting in a pipeline including bispecific T-cell engagers, antibody-drug conjugates, immune checkpoint modulators, and function-enhanced antibodies. Our vision is to transform lives by 2030 with Knock-Your-Socks-Off (KYSO) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with an international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com. Follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application. Note: Netherlands hires may be offered fixed-term contracts initially.
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