Consultant will analyze data using Statistical Analysis & Methodologies during clinical trials to prove if the drug or device is safe and effective. Provides design and execution for the research studies.
Project Details:
Serve as a study Biostatistician for multiple clinical studies
Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings
Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
Provide statistical input to data monitoring committee (DMC) charters, project management plans, and other study-level documents
Work with statistical programmers or CROs to generate tables, figures and listings
Support ongoing safety review and DMC review of the clinical development program/study teams
Perform ad hoc and exploratory statistical analyses as needed
Contribute to clinical study reports, including authoring of statistical sections, interpretation of the study results, and QC of the results in the reports.
Support regulatory submissions as needed
Support the preparation of publications, including manuscripts, posters and oral presentations
Job Experience:
MS in Biostatistics or equivalent with at least 5 years of relevant clinical trial experience or PhD in Biostatistics or equivalent with at least 3 years of relevant clinical trial experience
Knowledge of statistical methods for clinical trials
Proficient in statistical programming (SAS is required, and R is a plus)
Good communication skills and ability to work with cross-functional study teams
Ability to multi-task in an extremely fast-paced environment with changing priorities
Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan. Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefitsgroup@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.
