AD Biostat

in Pharma

Job Detail

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.