Job Summary (Primary function)
The Principal Biostatistician is responsible for providing statistical support for drug development programs in all phases of development.
Essential Functions of the Job (Key responsibilities)
- Participate in the development and enforcement of SOPs and guidelines.
- Participate in pre-IND and NDA activities.
- Participate and contribute to authoring of Clinical Development Plan.
- Assist in writing relevant sections of the clinical study report.
- Interpret study results and provide review of statistical summary reports of study results for accuracy.
- Provide guidance and support to team members in creating analysis dataset specifications and programming of tables, listings, and figures.
- Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
- Write statistical analysis plans.
- Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Familiarity with multivariate analyses and biomarker analyses is beneficial.
- Experience in collaborating with health authorities, including discussions and negotiations in filing strategies, is highly desirable.
- Proficiency in using SAS to perform efficacy analyses and validate important data derivations when necessary.
- Able to effectively communicate their ideas and to manage team members in a constructive manner.
- Demonstrate ability to work independently and collaboratively in project management and decision making.
- Experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics is preferred, but not required. We welcome candidates with diverse backgrounds and experiences.
- Advanced degree in statistics or equivalent experience preferred.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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