Associate Director, Biostatistics

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About the position

Responsibilities

  • Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans.
  • 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 design of eCRFs.
  • Provides statistical guidance on 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.
  • Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders.
  • Contributes to scientific articles, summarizing data collected in Alnylam 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.

Requirements

  • Ph.D. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 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.

Nice-to-haves

  • Experience in clinical development through Phase 3 (NDA submission).
  • Experience as lead statistician for a compound.
  • 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 designing and conducting adaptive trials.
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