Date: Mon, 19 Jul 2004 04:41:51 -0400
Reply-To: Bryan Mackie <bryan@FFORDE-MANAGEMENT.COM>
Sender: "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From: Bryan Mackie <bryan@FFORDE-MANAGEMENT.COM>
Subject: EXCITINFG NEW OPPORTUNITIES
Senior Expert Statistician:
1. Be the independent statistical leader and project manager for all B&SR
deliverables globally for a large and technically complex clinical
development program, including supervisory functions like appraisals of
full-time team members.
2. Ensure that clinical development program meets scientific, regulatory,
quality and commercialization requirements, through interaction with the
IPT and ICT (e.g., drive CDP and TPP development from a statistical
3. Be a scientific leader/expert within a TA, showing leadership/be the
point of refer-ence in statistical methods, regulatory guidelines, project
strategies, clinical devel-opment planning and study design in specific
4. Perform matrix management of B&SR project team, and mentor staff as
5. Ensure quality of scientific contributions, integrating input from ECD-
Biostatistics, Methodology, Modeling and Simulation and external experts.
Initiate and drive inno-vation by implementing novel methods and
6. Plan and track project level activities for B&SR, including resources.
7. Establish and maintain project standards (master analysis plan, full
development project specifications).
8. Plan and manage submission activities, like SCS, SCE, briefing books.
9. Participate in/lead non-clinical project activities.
10. Interact with Health Authorities and external consultants as
appropriate. Support and defend analyses and their interpretation at
Health Authority Meetings. Take sig-nificant Biostatistics leadership role
at FDA Advisory Committee meetings.
11. Evaluate in licensing opportunities.