My client is a key player in the Biotech industry globally, giving you the opportunity to be part of an international team providing high-class medicines to individuals & organizations across the world to help patients across multiple areas of Oncology, novel pharmaceutical and medical device products/therapies.
You will be leading the biostatistical methodology and execution expertise towards the planning, executing, analyzing, and reporting of pharmaceutical and medical device clinical research studies. The position offers an opportunity to expand your knowledge and skill sets in a collaborative environment that encourages showcasing your talent and progression in an impactful manner.
Key Responsibilities:
An independent biostatistical consultant to the Clinical Leadership team and project teams on all biostatistical aspects of clinical research and due diligence entities.
Leverages knowledge of biostatistical practices and methodologies in the medical device and pharmaceutical arena to advise on future project designs with continuous improvement objectives of quality, simplification, efficiency, and cost control. Provides analytic insight on biostatistical strategies from competitors and advises internal team with tactical strategies accordingly.
Review output across programs to ensure consistency under close supervision of senior biostatistician.
Review statistical sections of clinical study reports.
Work directly with sponsors, project managers, and external vendors on statistics-related project components.
Train and mentor new biostatisticians.
Key Requirements:
Master's degree / PhD or equivalent in Statistics, Biostatistics with 8+ years' experience.
Extensive knowledge with industry standards, such as the ICH guidelines, 21 CFR Part 11, and FDA guidelines.
Familiarity with statistical methods relevant to Phase I-IV clinical trials.
