Principal Biostatistician - Early Phase
Job Description: • The Principal Biostatistician is responsible for providing statistical support for drug development programs in early phases. Requirements: • Collaborate with multi-disciplinary project teams to establish project timelines. • Provide statistical input to study protocols. • Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts. • Write statistical analysis plans. • Monitor internal and CRO project activities including timelines, deliverables, and availability of resources. • Collaborates with Data Management, Clinical Development, and Clinical Operations with statistical expertise. • Contributes to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc. • Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures. • Interpret study results and review reports of study results for accuracy. • Participate and contribute to authoring of Clinical Development Plan. • Support exploratory analyses and medical affairs publications. • Participate in pre-IND and NDA activities. • Participates in other activities and meetings to support Biostatistics and the Development Team as needed. Benefits: • Home-based remote working opportunities • Work/life balance as well as flexible schedules • Collaborating with motivated, high-performance, statistical and research teams • Technical training and tailored development curriculum • Research opportunities that match your unique skillset • Promising career trajectory • Job stability: long-term engagements and re-deployment opportunities • Focus on bringing new therapies to market rather than project budgets and change orders. • Experience with regulatory submissions. • Engaging, fast-paced environment. • Good work-life balance. Apply tot his job