Director, Biostatistics - Copenhagen, Danmark - Genmab

Beskrivelse

The Role

The 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. This opportunity will be reporting to the Vice President, Biostatistics.

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
• 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 authorities on 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
• CRO selection and collaboration:
  • Perform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasks
  • Review scope of work (within own project) in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)
  • Attend operational and steering committee meetings, as applicable
• Support regulatory submission/filing activities

Requirements:

• Master's or PhD in a statistical discipline with 12+ years 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
• Experience leading and mentoring teams
• Proven performance in earlier role/comparable role

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

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 You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• 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
• 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 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.