Job Duties and Responsibilities:
Design, manage, and maintain the clinical study database in keeping with the protocols and amendments, standard operating procedures (SOPs), good clinical practices (GCP), and other regulatory requirements.
Review system specifications and Data Validation Plan (DVP) and perform programming and configuration activities for assigned projects
Participate in release to production activities
Develop and implement validation procedures for clinical studies and their appropriate tests and documentation.
Generate listings for manual data review
Contributing to the Data Management Plan (DMP)
Communicate progress on programming milestones to management and other stakeholders
Identify and communicate problems and propose solutions regarding possible data quality issues
Deliver milestones in a timely fashion for assigned projects
Provide input to protocol writing and forms design process
Provide input to contract department
Coordinate clinical programming resources and activities together with group heads
Coordinate the activities of other Clinical Programmers providing support as necessary
Support less experienced Clinical Programmers
Identify process, standards, or system enhancements and contribute to their continuous improvement
Perform other tasks that are related to clinical programming, data analysis and reporting as assigned
Oversee the project including leading the project team, communication with the client, ensuring adherence to timelines and budget responsibility, if assigned the Project Manager role for a project where no clinical Project Manager is assigned
Supervision of more junior Clinical Programmers within the assigned projects.
More Information: https://cho.tbe.taleo.net/cho01/ats/careers/requisition.jsp?org=CLINIPACE&cws=1&rid=4674
- ● 數學統計學門,數理統計學類,應用數學學類 相關科系
- 台北市信義區|月薪 32,470~40,580元月薪 32,470~40,580元|經驗不拘|大學、碩士、博士展開收合
【徵才單位】台北醫學大學癌症生物學與藥物研發研究所 楊培銘副教授實驗室 (網站: http://my2.tmu.edu.tw/yangpm)
【工作地址】汐止遠雄U-town實驗室 (新北市汐止區新台五路1段99號 A棟33樓之9)
【聯絡方式】firstname.lastname@example.org 請先寄送電子履歷表,再通知面試, 資格不合者恕不另外通知
- ● 醫學學類,藥學學類,醫學技術及檢驗學類 相關科系
Provides all biostatistical services to meet the requirements of all Clinipace clients, including full-service, Bioinformatics, and other type studies.
The specific job duties of a Biostatistician may include but are not limited to:
•Keep internal Biostatistics and Statistical Programming folders up to date with relevant study documentation.
•Develop Statistical Analysis Plans (SAP), mock-up tables, programming and derived dataset specifications as needed.
•Determine study randomization scheme from protocol and assume responsibility for providing a correct Randomization Specification for the study as needed.
•Provide oversight of programming and QC of derived datasets and Tables, Figures and Listings (TFL) in close cooperation with Statistical Programming.
•Lead data review to ensure clean data and proper evaluation and identification of all major protocol deviations prior to database lock.
•Provide all statistical analyses as needed.
•Write the statistical section of the Clinical Study Report (CSR) and collaborate with Medical Writing in preparing the integrated CSR.
•Assume responsibility for writing a Statistical Report as needed.
•Support protocol development including experimental design, randomization, sample size calculation, statistical methods, define study objectives and endpoints. Provide input on potential biostatistical implications on study design, conduct, and analysis of protocol amendments.
•Design of data integration concepts.
•Collaborate with Data Manager by reviewing study Data Management Plan (DMP), electronic case report forms (eCRFs) and edit check specifications.
•Attend internal and client-facing meetings.
•Assume responsibility for maintaining the statistical portion of the Trial Master File.
•Monitor study Biostatistics budget and report update to PM, regional Director of Biostatistics, and Director of Statistical Programming when budget limit is being reached.
•Monitor study Biostatistics timelines to ensure all are being met and that Units and Milestones (U&Ms) trackers are being recorded in a timely manner.
•Service IDMC/DSMB statistical requirements and attend their meetings as needed.
•Serve as interface between client and internal teams as needed, relay relevant information to appropriate client and internal stakeholders. Other duties commensurate with the position as assigned by line manager.
- ● 數學統計學門,數理統計學類,應用數學學類 相關科系