Statistical Analyst

该职位来源于猎聘 Job Responsibilities:

• Independently, perform SAS programming to create analysis datasets, table, listing and figures (TLFs) following CDISC standards and Statistical Analysis Plan’s requirements within timelines.
• With minimum guidance, develop analysis dataset specifications with precise descriptions based on established standards and project-specific requirements.
• Lead and/or oversee statistical programming activities and make statistical programming recommendations at project level. Co-ordinate activities of all programmers either internally or externally assigned to the study/studies.
• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (e.g., timelines, scope) as member of the Clinical Trial Team.
• Review eCRF, Edit Check Specification, SAP, mock-up shell and other key documents and provide input from statistical programming’s perspective.
• Comply with company’s existing SOPs and guidelines and develop statistical programming standards under the guidance of senior leadership.
• Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, medical monitoring report, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverable as well as accuracy and reliability of statistical analysis results.
• Maintain up-to-date knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and training.
• Work on innovative statistical programming solutions with the help of new technology to improve the quality and effectiveness, including but not limited to developing standard SAS macros and utilities, developing application for interactive graphic display using other languages such as R Shiny. Identify opportunities and independently develop or implement new tools, including AI-assisted programming solutions, to streamline statistical programming workflows. Job Qualification: 任职条件：
• BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related fields is required
• 5 years’ experience in pharmaceutical company or Clinical Research Organization (CRO) as statistical programmer with bachelor’s degree, or 3 years of relevant experience with master’s degree
• Fluent English in reading, writing and oral communication
• Positive working attitude and spirit of exploration Specialized Knowledge
• Extensive programming experience in SAS including Data step, Macros, Statistical procedures, and Output delivery system
• Good knowledge of CDISC standards including:
• Study Data Tabulation Model (SDTM)
• Analysis Data Model (ADaM)
• Use of Pinnacle21 to validate CDISC compliance
• Submission related deliverables
• Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology.
• Ability to manage work independently and take responsibility for end-to-end analysis activities.
• Knowledge of statistical methodology and regulatory requirements such as ICH E6 and E9
• Knowledge of software/computer language other than SAS, such as JMP, R or Python as a plus.
• Experience using AI assisted coding and tool development is a plus.