Manager/Senior Manager, Biostatistics

1 maand geleden

Utrecht, Nederland Genmab Voltijd

The Role

The 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.

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

  • 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

  • Contribute to clinical development plans

  • Arrange/attend lessons learned to share learnings

  • Represent Genmab during external meetings/congresses

  • Proactively engage in department activities

  • Actively participate various initiatives within the department

  • Proactively contribute to building a global Genmab organization 

  • May act as mentor for new employees or consultants

Requirements

  • MS / PhD or equivalent in a statistical discipline with 2+ - 5+ years of experience in relevant technical area

  • Experience in statistical analysis, modelling and simulation and adaptive trial designs

  • Experience in working with clinical trials

  • Preferred experience with oncology clinical trials

  • Proficient programming skills in statistical software’s, such as SAS

  • Excellent oral and written communication skills

  • Ability to work independently as well as in teams

  • Confident, self-reliant, and a quick learner

  • Proactive and open minded

  • Ability to prioritize and work in a fast-paced and changing environment

  • Result and goal-oriented and committed to contributing to the overall success of Genmab

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

$,.00---$,.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 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.

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