Description

**Remote in the US or Canada**

**Must be eligible to work in the US or Canada without restrictions**

Qualifications:

  • PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
  • MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
  • 2+ years of experience in statistical analysis of non-compartmental PK endpoints in pharmaceutical industry
  • Understanding of ICH GCP, regulatory guidance for clinical pharmacology studies and industry practices/standards.
  • Experience with CDISC, including SDTM, ADaM, CDASH.
  • Proficiency in SAS to perform analyses and validate important data derivations.
  • Knowledge of basic statistical modeling, simulations and PD/biomarker analyses

Job Responsibilities:

  • Collaborate with multidisciplinary project teams to establish project timelines.
  • Provide statistical input to study synopses and protocols.
  • Write the statistical sections of clinical trial protocols, including sample size calculations, while consulting with internal and external experts.
  • Review eCRF and other data management documents.
  • Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
  • Use SAS and/or R to perform inferential analyses and validate key data derivations.
  • Interpret study results and review reports of study results for accuracy.
  • Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
  • Collaborate with Data Management, Clinical Development, and Clinical Pharmacologists/PK with statistical expertise.
  • Contribute to clinical study reports and other regulatory documents e.g., DSURs, IB, etc.
  • Regulatory submissions