Trevena is looking for a Biostatistician to join our team. Reporting to the Vice President of Clinical Operations and Quantitative Sciences, the biostatistician will be responsible for all aspects of statistical design and analysis within the Company.
Specifically, the Biostatistician will;
1. Serve as a member of the portfolio review committee and core development teams to ensure that the appropriate statistical strategy is incorporated into the clinical development across all assets
2. Partner with the respective Heads of Clinical, Operations, Commercial, CMC, Medical Affairs and Regulatory Affairs to provide statistical expertise related to clinical development and submissions
3. Work closely with the statistics departments of existing and future partners to ensure timely delivery of data, analyses, and interpretation required for approval and marketing in non-US markets
4. Serve as a member of the publication review committee to ensure the appropriate interpretation and dissemination of statistical results for company assets
5. Work closely with the Commercial, Marketing and Regulatory Affairs teams to develop appropriate promotional material
6. Collaborate with CMC to help review assumptions used in the demand and supply chain models for approved products
7. Oversee statistical signal detection algorithms that are applied to post-approval data for unintended benefits and/or reported adverse effects
8. 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
9. Establish and maintain relationships of partners who will perform statistical functions on the behalf of Trevena
10. When statistical functions are outsourced, oversee the performance and execution of the outsourced activities
11. If required, hire and manage staff to support statistical activities
12. Communicate with regulators as required
13. Write and defend biostatistical regulatory documents
14. Observes all Trevena policies, SOPs and safety guidelines
15. Other duties as assigned
Submit your resume to email@example.com
Trevena does not accept unsolicited assistance from staffing or search firms for this or any other employment opportunity. Please, no phone calls or emails. All resumes submitted by staffing or search firms to any employee at Trevena via email, the Internet, in person or in any form and/or method without a valid, written and executed search agreement in place for this position shall be deemed the sole property of Trevena and no fee or other payment shall be paid in the event that the referred candidate is hired by Trevena.
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