Associate Director, Biostatistics
|Job Title:||Associate Director, Biostatistics|
|Location:||New Jersey, USA|
|Salary:||US$160000.00 - US$180000.00 per annum|
|Contact Name:||Cat Cappell|
|Job Published:||November 20, 2018 22:26|
This person will sit in the R&D team and you would report to the Head of Biometrics. It is an individual contributor who will be a hands-on lead statistician. They have a very healthy clinical trials pipeline running across a number of therapeutic areas (oncology, dermatology, respiratory) and you will be leading a late stage compound.
Provide strategic input to development programs including study design, analytic methods, endpoints that meet both regulatory and scientific requirements.
Ensure that technical reviews of all statistical deliverables are performed appropriately and accurately before being released.
Work alongside the Head of Biometrics and Director of Biostatistics to promote statistical expertise to optimize R&D activities.
Ensure contracts and relationships with CROs for Statistical activities are managed in an efficient, high quality and timely fashion
PhD in Biostatistics, Statistics or related field
Minimum 7 years of relevant industry experience in the statistical analysis of biomedical data.
Strong experience in the field of statistics in relation to one of the following TA: Oncology, Immunology/dermatology or Respiratory.
Strong experience with submissions and regulatory meetings, BLA/NDA experience required.
Good understanding of clinical development and regulatory approval process (FDA).
Ideally experience managing CRO's
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