发帖
雷达卡
Major Accountabilities：
· Serves as on-site expert for R&D China and works with regulatory, medical and clinical teams to prepare CTAs and NDAs with a strong mindset of quality, compliance, milestones, and regulatory approval · •Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met. This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions from published literature. · • Prepares relevant sections of protocols, especially those detailing the plans for data analysis, and justification for the sample size. Reviews entire protocol for consistency. · • Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately. · • Identifies potential threats to study credibility and validity, and works with study team to prevent, track, and manage potential problems. · • Writes the statistical analysis plan for the study and error-checking requirements for the study data. · • Takes responsibility for responding to relevant questions from regulators. · • Uses a variety of statistical methods and software tools to analyze and display data from clinical studies, appropriate for the kind of data collected. Required assumptions must be tested. · • Interprets clinical results and ensures data accuracy and consistency of regulatory submissions, reports, and manuscripts. |
• Prepares Results and Methods sections ofreports and manuscripts as needed.
Ideal Background：
· • 1+ years relevant experience in a clinical research organization and with a track record of phase II/III CTA and NDA preparation and approval (minimum 2 years in China) required · • Working experience in global Pharma/Biotech companies in US or China desirable |
• Research data management andprogramming skills with SAS and/or other software packages required
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