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