Senior/Principal Biostatistician
3 months ago
Our client is a scientifically-driven leader in the development of Oncology and Immunology therapies whose growing pipeline spans a variety of therapeutic approaches. They are currently seeking project-level Statisticians who, by providing statistical support, will be key contributors to drug development programs across a range of phases. Ideally this role will come in at the Senior or Principal level, but can be flexible based on experience.
In this role you will:
- Interact with members of the multidisciplinary project teams to establish project timelines.
- Provide statistical input to study protocols.
- Write statistical analysis plans.
- Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
- Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
- Interpret study results and provide review of statistical summary reports of study results for accuracy.
- Assist in writing relevant sections of the clinical study report.
- Participate and contribute to authoring of Clinical Development Plan.
- Participate in pre-IND and NDA activities.
- Participate in the development and enforcement of SOPs and guidelines.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Ph.D. degree in statistics required.
- 2-5 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics.
- Group Sequential Design experience
- Demonstrate ability to work independently in project management and decision making.
- Able to effectively communicate ideas and to manage programmers in a constructive manner.
- Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
- Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
- Knowledge of multivariate analyses and Biomarker analyses is a plus.
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Philadelphia, Pennsylvania, United States Penfield Search Partners Full time{"title": "Senior/Principal Biostatistician", "description": "Job SummaryOur client is a scientifically-driven leader in the development of Oncology and Immunology therapies whose growing pipeline spans a variety of therapeutic approaches. They are currently seeking project-level Statisticians who, by providing statistical support, will be key contributors...
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