Senior Biostatistics Manager

6 days ago


Charleston, West Virginia, United States Novotech Full time

About Novotech

We are a leading Asia-Pacific biotech specialist CRO with offices in 11 geographies across the region, and site partnerships with key medical institutions.

Our Mission

We provide clinical development services across all clinical trial phases and therapeutic areas, including feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management.

Award-Winning Team

We have accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. We are positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.

Career Opportunities

We are seeking an experienced Senior Biostatistics Manager to join our team. In this role, you will lead complex statistical analyses, create or provide input to statistical reports, and cooperate with other company departments to optimize global efficiency.

Responsibilities:

  • Develop strategies and evaluate the statistical resources needed to meet project goals.
  • Coordinate biostatistics-related project activities for successful completion within given timelines and budget.
  • Interact with internal and external clients regarding data analysis, scope of work, and budget.
  • Ensure compliance with applicable regulatory agency guidelines and SOPs in study design, protocol development, and statistical output.
  • Perform protocol development, sample size calculation, protocol and CRF review.

Requirements:

  • Masters or PhD with a major in statistics/biostatistics or related field and > 10 years of pharmaceutical industry, CRO, or related experience.
  • Experience leading Phase 3 programs and regulatory strategy study and design for Phase 3 programs.

What We Offer

We offer a competitive salary band of $140,000-165,000 based on your experience level.



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