There is nothing conditional about what we do.
Or who we are.
Or how we treat you.
We do what’s right.
We put science for patients first,
disrupting the model to go beyond
the concepts of conventional care.
We don’t treat a condition.
We treat people & partners.
We care to change the future.
Your Impact at TESARO:
The Director of Biostatistics provides direction on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures that standard procedures are followed within projects. The ideal candidate will be responsible for implementing consistent statistical conduct for the department and liaising with clinical research personnel in order to identify and meet their needs for statistical support. S/he will also interact with the head of statistical programming and data management to synchronize prioritization of projects and, in some cases, represent Biostatistics in meetings with executive committee, commercial, regulatory agencies, and external development partners in the absence of the Vice President of Biostatistics.
- Use advanced statistical techniques to analyze clinical study data. Ensure scientific integrity of the statistical methodology applied to clinical trials.
- Provide input to development programs including filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements.
- Collaborate with other functional areas within the company (Clinical Data Management, Clinical Research, Global Drug Safety, Regulatory and Project Management).
- Make presentations and may represent biostatistics to therapeutic leads, senior management, external collaborators, FDA meetings and medical and statistical meetings.
- Provide statistical direction and technical oversight for projects requiring statistical input.
- Support the presentation and publication of clinical trial results and contribution to advances on statistical topics.
- Clarify project deliverables and timelines for statistical analysis and reporting, and ensure that they are met.
- Utilize knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, simulation techniques, adaptive designs, and bioinformatics.
- Ph.D. in Statistics, Biostatistics or equivalent area with 10+ years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (12+ years) will be considered.
- 3+ years of scientific programming experience with SAS and R.
- Oncology drug experience and submission experience including NDAs/MAAs are preferred.
- Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used.
TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
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