Senior Biostatistician

Princeton, New Jersey
Competitive salary and benefits
May 27, 2018
Jul 27, 2018
Full Time

Senior Biostatistician

Genmab is looking for an experienced and dedicated Senior Biostatistician to be part of our Clinical Management Team. This position is based in our Princeton, NJ office.

The Role

Reporting to the Vice President, Head of Clinical Operations, the Senior Biostatistician will be responsible for running Clinical trials ranging from FIH trials to Phase III trials. The operational work within Clinical Operations is outsourced to Contract Research Organizations (CROs). The Senior Biostatistician will be involved in the oversight of the CROs various statistical assignments including trial design development, protocol writing, eCRF design, statistical analysis and sections of integrated clinical trial reports as well as presentations of results to internal and external stakeholders.

The Senior Biostatistician may also be an active member of the Core Development Team. The key responsibilities include but are not limited to:

•Providing statistical input into the design of clinical trials applying state of the art statistical designs/methodology needed to meet the overall objective and regulatory requirements

•Preparing input to protocols and statistical analysis plans

•Ascertaining that the clinical data is appropriately analyzed and reported

•Providing statistical support for integrated reports and submissions preparation

•Contributing to Clinical Development Plans

•Supporting preparation of manuscripts

•Interacting and coordinating activities with CROs and consultants

•Representing the company on statistical matters in meetings with regulatory authorities, key opinion leaders and similar experts / bodies

•Quality control of statistical deliverables

Key Accountabilities

•PhD in a statistical discipline

•Thorough understanding of statistical issues

•At least 3-5 years of industry experience in statistical analysis within a clinically related subject

•Experience with oncology trials

•SAS programming skills

•Good 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 lead teams and inspire trust among colleagues

•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