Biostatistician

Responsibilities:

• Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.
• Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• Contributes to or prepares statistical analysis plans.
• Collaborates with Data management, Clinical Development, and Clinical Operations on the design of eCRFs.
• Provides statistical guidance on the conduct of ongoing trials.
• Collaborates with Statistical Programmers on summary and analysis of trial data.
• Writes ADS and ad hoc analysis specifications.
• Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
• Contributes to scientific articles, summarizing data collected in trials.
• Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
• Consults with Research & Preclinical colleagues on statistical questions in their work.
• Manages CRO statistical and programming support.

Qualifications:

• Ph.D. in Biostatistics, Statistics, or Equivalent with at least 5 years of pharmaceutical biostatistics experience; or MS with at least 8 years relevant experience.
• Excellent written and oral communication and presentation skills.
• Experience programming in SAS.
• Interest in and basic understanding of biology and biological processes, including RNAi.
• Experience in clinical development through Phase 3 (NDA Submission)
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Proficiency in R programming language and other statistical software, including EAST.
• Experience with CDISC, including SDTM, ADaM, CDASH.
• Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities
• Experience in drug development for rare genetic diseases.