锦鲤求职岗位描述
Responsibilities:
Actively participate in and contribute to decision making related to clinical development strategies and regulatory strategies.
Provide strategic statistical input to feasibility assessments, clinical development and submission plans, and defense of regulatory submissions. Negotiate timelines (statistical) at compound level.
Play a leadership role in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
Oversee definition and implementation of compound-level database (including ADaM datasets), analysis and reporting standards.
Coordinate with Data Management, Programming CRO, Clinical to target high quality databases and specifications at compound level.
Identify compound level vendor requirements and participate in the evaluation/selection of vendors. Provide compound level analytical oversight of statistical activities of external vendors/CROs to plan and ensure timelines and achieve high quality statistical outputs.
Interact with external statistical experts for issues related to study design, methodology and results.
Monitor industry advances and FDA/CDE guidance documents in statistical methods to optimize study designs and statistical analysis methods and implement innovative approaches at a compound level.
Mentor junior statisticians.
Report to Head of Statistics and Programming
Requirements:
Ph.D. in statistics, biostatistics, or biometry with more than 7 years of experiences in pharma or CRO. Or MS in relevant majors with more than 10 years of experiences in pharma or CRO.
Advanced knowledge of clinical study designs, common analysis methods including statistical tests and modeling.
Advanced knowledge of clinical drug development process and relevant ICH/FDA/CDE guidance.
Good knowledge of statistical programming languages (SAS or R), software (such as PASS, EAST). Excellent oral and written communications skills.
Strong project management skills.
Strong collaborative skills and ability to work with a cross-functional team.