Position: Biostatistician/Senior Biostatistician
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Biostatistician will be a key member of clinical study teams responsible for the development and conduct of statistical analyses contributing to the submission of publications and presentations arising from Karyopharm-sponsored clinical studies. Duties will include participate in designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation and reporting of preliminary and final study results. The ideal candidate is a good communicator with high- energy, self-motivated and a forward thinker.
- Be accountable for all statistical aspects of protocols and regulatory submissions for assigned clinical studies.
- Work with clinical, pharmacovigilance, and regulatory personnel in preparation of statistical documents (e.g. statistical analysis plans) and analyses (e.g. safety and efficacy analyses) to support DSMB/DMC meetings, Development Safety Update Reports, and investigative brochures.
- Work with data management personnel in the preparation of data sets that are of high quality and in usable format.
- Work with medical writing personnel in preparation of clinical study reports and other regulatory documents including NDA
- Proactively mentors and trains subordinates to continually improve processes and procedures in support of internal and external customers.
- Guide team in the design and analysis of clinical studies using appropriate and innovative statistical methods.
- Review draft presentations and training materials, including posters and slide decks, according to deadlines.
- M.S or Ph.D. in Statistics, Applied Mathematics or related fields.
- Level (title) will be adjusted based on years of industry experience.
- Demonstrated ability to effectively contribute to the statistical aspects of clinical protocol design, data interpretation, review and reporting of results for multiple studies and projects.
- Practical experience with application of advanced statistical methodologies to clinical trial design/analysis and with regulatory reporting/submissions.
- Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development.
- Strong written verbal and written communication skills.
- Ability to communicate statistical information to non-scientists, willingness to educate internal team.
- Ability to work in a fast-paced environment.
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