Job Description:
Responsibilities and Duties:
Additional Info:
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Responsibilities and Duties:
- 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 6 years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (8 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.
Requeriments :
Skills :
Additional Info:
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