Genmab
Director, Biostatistics
Genmab, Plainsboro, New Jersey, United States, 08536
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 RoleThe 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 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/indicationFollow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendorSupports 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 CDTProvide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicableDrive design and synopsis development together with relevant stakeholdersEnsure transparent communication to relevant stakeholders from the CDTEnsure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needsSupport 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 networkingEngage with regulatory authorities on trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab during Key Opinion Leaders meetingsEnsure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicableEnsures state of the art statistical work which includes but is not limited to:Applying adequate methods for which a solid scientific foundation existsEnsure proper documentation of work doneKeep oversight and QC essential documents/data provided by vendorsEnsure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP
CTT member:
Participate and represent BiostatisticsReview and provide input to protocol and amendment developmentPerform vendor oversight according to applicable SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.Review assay validation reports, as applicablePerform exploratory analysis, ad hoc analyses, and modelling of dataReview and approve randomization and stratification plansPerform UAT of Randomization part of the IRT system as applicableEnsure procedures for blinding are in place as applicableSupport timely delivery of statistical deliverablesResponsible for planning and conducting trial result meetingsReview and approve the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review, and approval of data packages for Data Monitoring CommitteesReview and approve any amendments, corrections, and updates of data packagesSupport regulatory submission/filing activities
Requirements:
Master's or PhD in a statistical discipline with 12+ years of experience in relevant technical areaExperience in statistical analysis, modelling and simulation and adaptive trial designsExperience with drug development in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA, EMA, and ICH guidance for drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategiesExperience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissionsExperience directing multiple complex projects/studies in a technical capacityExperience leading and mentoring teamsProven performance in earlier role/comparable role
This role can be based in Copenhagen, Denmark; or Princeton, NJ USA and is hybrid.
For US based candidates, the proposed salary band for this position is as follows:
$170,625.00---$284,375.00The 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 treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou 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.
The RoleThe 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 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/indicationFollow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendorSupports 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 CDTProvide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicableDrive design and synopsis development together with relevant stakeholdersEnsure transparent communication to relevant stakeholders from the CDTEnsure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needsSupport 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 networkingEngage with regulatory authorities on trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab during Key Opinion Leaders meetingsEnsure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicableEnsures state of the art statistical work which includes but is not limited to:Applying adequate methods for which a solid scientific foundation existsEnsure proper documentation of work doneKeep oversight and QC essential documents/data provided by vendorsEnsure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP
CTT member:
Participate and represent BiostatisticsReview and provide input to protocol and amendment developmentPerform vendor oversight according to applicable SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc.Review assay validation reports, as applicablePerform exploratory analysis, ad hoc analyses, and modelling of dataReview and approve randomization and stratification plansPerform UAT of Randomization part of the IRT system as applicableEnsure procedures for blinding are in place as applicableSupport timely delivery of statistical deliverablesResponsible for planning and conducting trial result meetingsReview and approve the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety:Participate in definition, review, and approval of data packages for Data Monitoring CommitteesReview and approve any amendments, corrections, and updates of data packagesSupport regulatory submission/filing activities
Requirements:
Master's or PhD in a statistical discipline with 12+ years of experience in relevant technical areaExperience in statistical analysis, modelling and simulation and adaptive trial designsExperience with drug development in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA, EMA, and ICH guidance for drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategiesExperience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissionsExperience directing multiple complex projects/studies in a technical capacityExperience leading and mentoring teamsProven performance in earlier role/comparable role
This role can be based in Copenhagen, Denmark; or Princeton, NJ USA and is hybrid.
For US based candidates, the proposed salary band for this position is as follows:
$170,625.00---$284,375.00The 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 treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou 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.