Biostatistics Senior Manager, Rare Disease

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Requirements:

• Doctorate degree and 2 years of industry experience OR Master’s degree and 4 years of industry experience OR Bachelor’s degree and 6 years of industry experience OR Associate’s degree and 10 years of industry experience OR High school diploma / GED and 12 years of industry experience
• Life Cycle Drug Development Experience (Pre-clinical Development, Clinical Development, and Post-marketing)
• Experience in Inflammation therapeutic area clinical development
• Strong verbal and written communication combined with organizational skills and cross-cultural sensitivity
• Statistical leadership and contribution to regulatory and reimbursement submissions. of regulatory guidelines.
• Experience working effectively in a globally dispersed team environment with cross-cultural partners.

Responsibilities:

• Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs, and Business Development
• Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs
• Serve as primary author for statistical sections of protocol
• Create accompanying statistical documents (e.g., statistical analysis plan and mocked shells)
• Participate in development of EDC database and interactive response technology (IxRS) specifications
• Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions
• Implement innovative statistical techniques that will provide benefit to clinical development programs
• Contribute to strategic planning and go/no go decision guidance
• Review biostatistics and statistical programming tasks outsourced to vendors
• Perform statistical analyses and create statistical text for clinical publications and other communications, perform SAS programming validation if needed
• Support the preparation of regulatory submissions documents including summaries of clinical safety and efficacy of BLA/NDAs if needed
• Ensure timeliness and quality of deliverables
• Travel as needed to execute assigned responsibilities.