Principal Statistical Programmer- US Timings

3 weeks ago

London, United Kingdom Tech Observer Full time
Tech Observer

is a Global CRO with HO in NJ, USA and presence in other 20+ countries-India, Denmark, UK, Singapore etc. ( are hiring for following roles on

FSP:

a.

Statistical programmers

: 5-8 years of exp in clinical SAS ProgrammingnSenior Statistical Programmers : 8-12 years of exp in clinical SAS Programmingnb.

Principal Statistical programmers

: 12+ years of exp in clinical SAS Programming

Location -United Kingdom (candidates eligible to work in UK shall be considered)

Work Timings : US Timings (EST -3 days and PST -2 days)

Job Responsibilities-

1.Compliance with working SOPs within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensure adherence to programming guidelines.n2. Implement and follow the latest versions of CDISC, FDA Guidelines, GCP and other industry standards.n3. Participate in and co-ordinate the Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study related documentation (e.g. data validation guidelines).n4. Review and interpret Report and Analysis Plans and provide comments for assigned projects.n5. Develop and review SAS programs and output for the management of clinical trial data, the tabulation of data, preparation of patient data listings, graphical output, and creation of derived datasets and statistical analysis of data as specified in the Statistical or Report Analysis Plans.n6. Develop SAS programs for ad hoc tables and listings. Write, modify, and maintain programs that produce diagnostics and listing for data review in support of Data Managementn7. Carry out electronic data transfer (both incoming and outgoing). Develop and review programs to ensure the data transfer has been produced to specification.n8. Design and set-up utilities/SAS based systems to assist and facilitate Clinical Data Management activities.n9. Review draft and final production runs for projects to ensure quality and consistency.n10. Provide feedback for continuous improvement of SOPs from BPP and other cross functional SOPs.n11. Ensure quality of personal work and the work of the team when acting as a Lead Programmer or Biometrics Project Manager.n12. Assume team member responsibilities, including representing Statistical Programming at internal project team meetings, client meetings and audits.n13. With sufficient experience may support the activities of senior Statistical Programming staff by providing input into time and cost estimates and presentations to clients.n14. Advise Senior Statistical Programming staff of changes in scope of projects to enable the timely development of change orders.nDemonstrate excellent problem solving skills, a proactive approach and a willingness to take decisions on a regular basis.n16. Encourage and participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually improved.n17. Maintain awareness of new developments in programming techniques and IT which may be applied to the management and reporting of clinical trial data.n18. Perform other duties as assigned by senior Statistical Programming staff.

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