The Companion Diagnostics (CDx) Statistician will support all statistical and statistical programming activities that enable the development and execution of the integrated companion diagnostics strategies for *** programs.
The Statistician will provide statistical and data-analytic support for the design and subsequent analyses of molecular and clinical data from design verification, analytical performance characterization and clinical validation studies in conjunction with registrational clinical trial assays (rCTA) and IVD CDx device development and registration.
The candidate will work with cross functional teams of scientists, engineers, clinical and regulatory experts
Manage resources and priorities. Candidates with several years of experience will also be expected to help mentor junior team members.
Establish and maintain excellent collaborative relationships with internal and external scientific groups involved in analysis
Establish and maintain sound working relationships and effective communication within Biomarkers and Diagnostics Biometrics (BDB) and BDM.
Follow processes and adhere to *** and project specific standards as well as Health Authority requirements (SOPs, BGs, Master Analysis Plan, GCP, and regulatory guidelines).
English Complete understanding and wide application of technical principles, theories and concepts in the field of (companion) diagnostic Statistics.
Familiarity with methods for the design/optimization/verification of IVD devices under design control (e.g. DFSS, DoE, RSM), is desirable.
Familiarity with Oncology Statistics and/or regulatory activities would be advantageous. Experience in Software Engineering would be advantageous.
Proven knowledge and expertise in statistics and its application to analyze laboratory data, data mining and/or bioinformatics and their applications to clinical trials. Experience with a wide range of advanced statistical methods.
Knowledge of statistical software packages (e.g. SAS, R, JMP).
Good communication and presentation skills. Excellent team player.
MS in statistics with 2+ years relevant work experience or PhD in statistics with no work experience
Expertise in SAS programming is a must
Fluent English (oral and written)
Good communication skills
Source: Job Diva – Job Listing