Genmab A/S
Manager/Senior Manager, Biostatistics
Genmab A/S, Trenton, New Jersey, United States,
The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com.Manager/Senior Manager, Biostatistics
Locations: Princeton, NJ; Utrecht; CopenhagenTime Type: Full timePosted on: Posted 6 Days AgoJob Requisition ID: R9104At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Senior 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 Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, 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 Senior 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.ResponsibilitiesAct 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 discussionsEnsure consistency of statistical methods and data handling across trialsEnsure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendorSupport compound responsible programmer in developing an integrated database specificationRepresent Genmab during meetings/congresses and courses and perform professional networkingEngage with regulatory authorities on trial level discussionsCoordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicableContribute to clinical development plansProactively engage in department activitiesMay act as mentor for new employees or consultantsRequirementsMS / PhD or equivalent in a statistical discipline with 2+ - 5+ years of experience in relevant technical areaExperience in statistical analysis, modelling and simulation and adaptive trial designsExperience in working with clinical trialsPreferred experience with oncology clinical trialsProficient programming skills in statistical software, such as SASExcellent oral and written communication skillsAbility to work independently as well as in teamsConfident, self-reliant, and a quick learnerProactive and open mindedAbility to prioritize and work in a fast-paced and changing environmentResult and goal-oriented and committed to contributing to the overall success of GenmabFor US based candidates, the proposed salary band for this position is as follows: $114,375.00---$190,625.00. 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.About YouYou 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 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 soLocationsGenmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance.About GenmabGenmab 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. 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 inclusionWe are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.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.
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Locations: Princeton, NJ; Utrecht; CopenhagenTime Type: Full timePosted on: Posted 6 Days AgoJob Requisition ID: R9104At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Senior 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 Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, 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 Senior 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.ResponsibilitiesAct 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 discussionsEnsure consistency of statistical methods and data handling across trialsEnsure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendorSupport compound responsible programmer in developing an integrated database specificationRepresent Genmab during meetings/congresses and courses and perform professional networkingEngage with regulatory authorities on trial level discussionsCoordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicableContribute to clinical development plansProactively engage in department activitiesMay act as mentor for new employees or consultantsRequirementsMS / PhD or equivalent in a statistical discipline with 2+ - 5+ years of experience in relevant technical areaExperience in statistical analysis, modelling and simulation and adaptive trial designsExperience in working with clinical trialsPreferred experience with oncology clinical trialsProficient programming skills in statistical software, such as SASExcellent oral and written communication skillsAbility to work independently as well as in teamsConfident, self-reliant, and a quick learnerProactive and open mindedAbility to prioritize and work in a fast-paced and changing environmentResult and goal-oriented and committed to contributing to the overall success of GenmabFor US based candidates, the proposed salary band for this position is as follows: $114,375.00---$190,625.00. 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.About YouYou 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 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 soLocationsGenmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance.About GenmabGenmab 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. 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 inclusionWe are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.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.
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