Associate Director, Biostatistics
Trevena, a publicly-traded, commercial stage biopharmaceutical company located in Chesterbrook, Pennsylvania is is looking for a Biostatistician at the Associate Director level to join our team. Reporting to the Director, Quantitative Sciences, the Associate Director, Biostatistics will be responsible for all aspects of statistical design and analysis within the Company.
Specifically, the Associate Director, Biostatistics will;
- Serve as a member of core development teams to ensure that the appropriate statistical strategy is incorporated into the clinical development across all assets,
- Work closely with colleagues in Clinical Development, Clinical Operations, Nonclinical Development, Commercial, CMC, Medical Affairs and Regulatory Affairs to provide statistical expertise,
- Work closely with existing and future partners to ensure timely delivery of data, analyses, and interpretation required for approval and marketing in non-US markets,
- Work closely with the Commercial, Marketing and Regulatory Affairs teams to develop appropriate promotional material,
- Design, review and execute Statistical Analysis Plans in a timely manner using both internal and external partnerships and assure the studies are completed within the appropriate regulated environment,
- Establish and maintain relationships of partners who will perform statistical functions on the behalf of Trevena,
- Communicate with regulators as required including writing and defending biostatistical regulatory documents,
- Observes all Trevena policies, SOPs and safety guidelines,
- Other duties as assigned.
Up to 30% domestic/international travel.
EDUCATION & EXPERIENCE
- Graduate degree in statistics (M.S.,PhD or equivalent) and ideally 1-3 years of experience in biostatistics within the pharmaceutical/medical device industry. New Ph.D. graduates may be considered.
KNOWLEDGE, SKILLS & ABILITIES
- Demonstrated ability to identify multiple potential courses of action and describe related risks of each to non-technical audiences,
- Familiarity with appropriate regulatory guidelines,
- Working knowledge of CDISC standards,
- Excellent SAS programming skills,
- Knowledge of the R programming language is a plus,
- High attention to detail.
Please fill out the form below to submit your application.