Job Description
Job Description Responsibilities: - Perform or supervise complex statistical analyses and create or provide input to statistical reports.
- Cooperate with other company departments to optimize global efficiency.
- Act as a pro-active advisor for all types of analysis during the proposal process as well as during the project life cycle.
- Define strategies and evaluate the statistical resources needed to meet the defined project goals.
- Coordinate Biostatistics related project activities for successful completion within given timelines and budget.
- Interact with internal and external clients with regard to data analysis, scope of work, and budget.
- Ensure compliance with applicable regulatory agency guidelines and Novotech
- SOP's in study design, protocol development and all other statistical output.
- Perform protocol development, sample size calculation, protocol and CRF review.
Minimum Qualifications & Experience :
- Masters or PhD with a major is statistics/biostatistics or related field with > 10 years of pharmaceutical industry, CRO or related experience.
- Experience leading Phase 3 programs and regulatory strategy study and design for Phase 3 programs.
Salary Band - $140,000-165,000 Salary offered will be based on candidates experience level.
About Us Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.
Novotech provides 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. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
About the Team Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.
It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK. Novotech
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