A green field opportunity to grow a team of statisticians, my client is
looking to take on a senior clinical statistician to grow a team around
them....

This would suit a senior statistician who is looking for their first career
move into management ????

• Responsible for development of Statistical Analysis Plans, to
include statistical methodology, statistical programming procedures,
definition of derived variables, data–handling rules and mockups.
• Responsible for Biostatistics’ deliverables within assigned
projects.
• Develop and coordinate QC procedures for Biometrics deliverables,
ensuring activities are appropriate for effectively and efficiently
delivering quality output within a specific project.
• Statistical analysis of clinical trial data and related decision
making.
• Responsible for statistical input to statistical reports and
Clinical Study Reports.  Authorises final reports as one of The
clientsignatories.
• Provide statistical guidance in development of clinical research
program and in design of individual studies as part of multi-disciplinary
team; responsible for statistical input to protocol; approves protocol as
signatory.
• Provide statistical input into design/review of format of CRFs.
• Supervision of less-experienced statisticians within project
activities.
• Statistical/Biometrics lead for large global or other major
programs.
• Prepare randomisation specifications; generate schedules; verify
randomisation components (specification and schedule). Provide input into
planning activities related to the preparation of, distribution of and
access to randomisation and unblinding information.
• Project management activities for identified projects including
financial, resource planning and utilisation, timelines and milestone
management.
• Determine documentation requirements for Biostatistics’ aspects of
projects.  Give guidance to support business and regulatory requirements
including definition of appropriate documentation, storage/communication
media, and retention/return of documents at study close-out.
• Provide statistical input into other disciplines’ activities and
participate in interdepartmental processes.
• Independent peer review of statistical deliverables, eg, protocols,
Statistical Analysis Plans, Tables, Figures and Patient Data Listings,
statistical reports, Clinical Study Reports.
• Provision of technical solutions and advice to The clientstaff and
to clients on statistical methodology and principles.
• Provide support for special committees, eg, DSMBs, including
input/review of charters, and ensuring maintenance of appropriate blinding.
• SAS programming and related activities for the presentation and
analysis of clinical trial data.
• Ensure mechanisms in place to maintain flow of appropriate
information between disciplines on project team.
• Contact with client across multiple disciplines.
• Training and development of less-experienced staff within the
department.
• Contribution to review and amendment of departmental processes and
supporting documentation.




Natalie Fforde
Managing Director
Fforde
Curtis House
34 Third Ave
Hove
BN3 2PD

Tel: 01273 722366
Fax: 01273 325350
Mobile: 07769 700 222
Email: [log in to unmask]