Genmab
Associate Director, Biostatistics
Genmab, Princeton, New Jersey, us, 08543
At 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 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 authorities on compound/indication level discussions
Ensure consistency of statistical methods and data handling across trials
Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
Support 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
Drive design and synopsis development together with relevant stakeholders
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 authorities on trial level discussions
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
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
Ensure timely delivery of statistical deliverables
Attend trial and investigator meetings if/as needed
Experience:
Master's or PhD in a statistical discipline with 8+ years of experience in relevant technical area
Experience in statistical analysis, modelling and simulation and adaptive trial designs
Experience with drug development in biologics and targeted therapies preferred
Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities
Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
Proven performance in earlier role/comparable role
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 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
LocationsGenmab 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 team to strive towards improving the lives of patients through innovative antibody therapeutics.
Our commitment to diversity, equity, and inclusionWe are committed to fostering workplace diversity at all levels of the company. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex, national origin, age, disability, or genetic information.
#J-18808-Ljbffr
The RoleThe 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 authorities on compound/indication level discussions
Ensure consistency of statistical methods and data handling across trials
Ensure all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
Support 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
Drive design and synopsis development together with relevant stakeholders
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 authorities on trial level discussions
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
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
Ensure timely delivery of statistical deliverables
Attend trial and investigator meetings if/as needed
Experience:
Master's or PhD in a statistical discipline with 8+ years of experience in relevant technical area
Experience in statistical analysis, modelling and simulation and adaptive trial designs
Experience with drug development in biologics and targeted therapies preferred
Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities
Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
Proven performance in earlier role/comparable role
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 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
LocationsGenmab 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 team to strive towards improving the lives of patients through innovative antibody therapeutics.
Our commitment to diversity, equity, and inclusionWe are committed to fostering workplace diversity at all levels of the company. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex, national origin, age, disability, or genetic information.
#J-18808-Ljbffr