美商布萊特有限公司

1. Reads and analyzes protocol, statistical analysis plan, CRF and other trial design documents and discusses with other team members such with as biostatisticians and data managers. 2. Develops and debugs simple to complex SAS program in a timely manner 3. Implements statistical analysis plan, data preparation, and data manipulation into SAS programs and macros 4. Create analysis datasets, statistical tables, figures, and listing for clinical trial data. 5. Create CDISC standard datasets (SDTM and ADaM) 6. Participates in the validation of SAS programs and analysis datasets 7. Maintains documentation for SAS programs and validation results 8. Leads and coordinates the programming work for projects involving SAS programming if necessary 9. Coordinates timelines in orders to fulfill the needs of other departments

1. Reads and analyzes protocol, statistical analysis plan, CRF and other trial design documents and discusses with other team members such with as biostatisticians and data managers. 2. Develops and debugs simple to complex SAS program in a timely manner 3. Implements statistical analysis plan, data preparation, and data manipulation into SAS programs and macros 4. Create analysis datasets, statistical tables, figures, and listing for clinical trial data. 5. Create CDISC standard datasets (SDTM and ADaM) 6. Participates in the validation of SAS programs and analysis datasets 7. Maintains documentation for SAS programs and validation results 8. Leads and coordinates the programming work for projects involving SAS programming if necessary 9. Coordinates timelines in orders to fulfill the needs of other departments

• Participates in study design; sample size estimation, protocol writing • Develop Statistical Analysis Plan and output shells • Create ADaM specifications. • Perform validation on statistical analysis and QC output (Tables/Listing/Figures). • Participates in clinical trial project meetings. • Applies statistical methodology to clinical trials. • Acts as a project statistician interacting with clients and co-workers. • May present and interpret study results. • May provide consultation to clients regarding statistical and mathematical questions pertaining to the design and interpretation of clinical studies. • Performs additional tasks as assigned.

• Performs ongoing Data Management activities such as data review (based on programmed edit checks and or externally generated listings), external vendor data processing, external vendor data reconciliation, SAE reconciliation, medical coding. • Prepares and maintains clinical Data Management documents on study level, including but not limited to Data Management Plans, eCRF Completion Guidelines, Edit Check Specifications, and SAE Reconciliation Plan. • Performs User Acceptance Testing (UAT) for all assigned studies and ensure associated documentation is maintained. • Performs Quality Data Review on assigned studies. • May coordinate with internal Information Technology team or EDC vendor to perform activities such as eCRF development, database development, and edit check programming • May perform SAS programming tasks, as assigned.

Key Accountabilities: 1.Perform data entry and processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial Sponsors’ requirements. 2.Assist the primary Data Manager in performing data management activities. These activities include, but are not limited to, writing Data Management Plans (DMP; including specifying database integrity checks), designing clinical trial Case Report Forms (CRFs), designing databases, monitoring data flow, and quality control processes. 3.Write draft DMPs using standard DMP template. 4.Assist in defining and monitoring clinical trial data flow and quality control processes in accordance with corporate standard operating procedures (SOPs), Good Working Practices, and divisional guidelines. 5.Assist in designing and reviewing patient CRFs and database schema. Test data capture/entry screens and edit specifications. 6.Assist in designing databases following database design standards and conventions that have been established by the company or the trial Sponsor. 7.Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks. 8.Assist in performing data quality control procedures during the trial and additional database closure checks at the end of the study. 9.Validate and distribute study monitoring reports to internal and external study team members. 10.Assist in resolving data coding discrepancies resulting from the coding of medical events, procedures, and medications. 11.Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving such documentation. 12.Assist data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema and databases for assigned studies. These QA procedures include, but are not limited to, the following: performing line-by-line checks on subject data listings against completed CRFs; comparing database schema against annotated CRFs; comparing final paper CRFs against CRF images that were captured during the trial. Qualifications and Experience: A Bachelors’ or Masters’ degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields. Education or experience must demonstrate the ability to work independently and to apply data management concepts, clinical trial data capture and management techniques, and logical and algebraic operations.

JOB ACCOUNTABILITIES: Interact with personnel from study sponsors, investigational sites, vendors, and Everest functional groups to enable timely and high quality initiations and completions of clinical trials. Compile documentation for qualification of clinical sites. Support review of that documentation to ensure that those clinical sites comply with ICH-GCP and relevant local regulations. Assist with preparation and submission of regulatory documents to responsible authorities and IRB/ECs. Responsible for set-up and maintenance of studies in Clinical Trial Management System (CTMS) and Trial Master File (TMF). Establish, maintain, and archive files of essential documents from investigative sites and for inclusion in Trial Master Files. These files must be maintained in a fashion so that they are continuously available for audit and completion for archive. Contribute to the development of documents that facilitate or describe the management of the clinical trial. Examples of such documents include, study guides or manuals, and information collection tools. Assist in review of documentation of information provided to study subjects, including informed consent forms. Assist in working with meeting planners and vendors to arrange for investigator meetings, off-site client or internal departmental meetings. Responsible for the shipment and tracking of trial documents (site binders, manuals, guides, etc.). Record and inventory visit reports received from monitoring staff. Maintain study portals, web sites, or newsletters. Compile reports progress/status of investigational sites. Assist with processing vendor invoices, investigator payments, and expense reports. Prompt staff to provide timely and accurate reports of travel expenses. Participate in the development and maintenance of, and adhere to departmental SOPs and guidelines. Prepare, maintain, and complete training on study-specific and (or) applicable sponsor SOPs. Support sites in their efforts to prepare for audits conducted either by sponsors or regulatory authorities. Plan and carry out professional development. Provide support in Clinical Operations or other functional areas as required. QUALIFICATIONS: Bachelor’s degree in Life Sciences or health-related field preferred. Excellent command of verbal and written English. Expert use of the MS Office suite is essential. Minimum of one year of experience in administrative support required. Knowledge of ICH-GCP. Experience in organizing Trial Mater Files desired. Ability to travel a maximum of 5% of working hours is required.。