Statistical Organizational Structure
Statisticians within a Cross-Functional Team versus a Pure Statistical Research Environment
Following the overall theme of JSM 2000 of "Celebrating Diversity in Statistics," the Invited Session sponsored by the host Central Indiana chapter of ASA will explore and debate alternative organizational structures for statisticians in the pharmaceutical industry. Speakers from pharmaceutical companies, CROs and academia will describe their perspectives on a variety of organizational issues.
Session Chair: Stacy R. David, Lilly Research Laboratories
Session Organizers: Vipin Arora, Ami Claxton, Stacy David, Bill Huster, Bob Obenchain, and Ouhong Wang
Tim Church, Associate Professor, Environmental and Occupational Health, University of Minnesota
Making it Work: Experience as a Consulting Statistician in an Academic Environment
The demands on a biostatistician working within a diverse faculty consisting of epidemiologists, chemists, engineers, toxicologists, nurses, physicians, and microbiologists are infinitely varied and usually surprising. The flexibility required is acquired through experience over a long period of time and a few tricks of the trade make the adaptations easier. Three features distinguish the skills needed for such an environment from those needed in a functionally homogeneous environment: broad vision, short-term horizons, and quick summarization vs. depth of knowledge, long-term involvement, and collaboration. Although all six characteristics are necessary for any biostatistician, the three former are more often needed when immersed in a diverse faculty than when a member of a biostatistics faculty. The talk will conclude by contrasting the experience of a consulting statistician with that of a biostatistics faculty member through the recounting examples to illustrate those differences.
Jim Neaton, Professor of Biostatistics, University of Minnesota
Making it Work: Experience with a Centralized Biostatistical Unit in an Academic Environment
A number of multi-center clinical trials are coordinated by a unit within the Division of Biostatistics at the University of Minnesota called the Coordinating Centers for Biometric Research (CCBR). The advantages of a centralized unit such as the CCBR are many, foremost being opportunities for collaboration, peer support and review. The CCBR has a staff of 70 persons, including 6 faculty from Biostatistics who direct CCBR projects. The CCBR full-time staff (excluding faculty) includes 6 Ph.D. statisticians, 14 masters level statisticians/epidemiologists, database management and networking experts, and data processing and administrative support staff. Other faculty, who perform primarily statistical research, frequently carry out joint work with CCBR staff on issues arising in collaborative research projects.
CCBR staff work on specific projects so that they can invest time in understanding the applied area (e.g., HIV/AIDS, hypertension, pulmonary disease). Methods and software tools developed for specific projects, however, are shared among staff. This is facilitated through the computing network, web pages, seminars, and by faculty who direct multiple projects. In addition, CCBR projects share computer services, statistical software, space, photocopying and mailing facilities, and administrative staff.
Alvin H. Rampey, Jr., Ph.D., COO of the Zyprexa Product Team, Lilly Research Laboratories
Product Teams: A Positive Experience within the Pharmaceutical Industry
Although cross-functional, co-located, dedicated product teams have been widely used in the telecommunications and automobile manufacturing industry for years, their application in the pharmaceutical industry is relatively new. Pharmaceutical company statisticians have traditionally been located administratively within a central statistics function and have been allocated to various product development programs on an ad hoc basis. Functionally located statisticians are generally responsible for supporting multiple compounds in various stages of development, and may have little opportunity for interaction with colleagues working on the same product. The product team structure affords an opportunity for statisticians to be located with their cross-functional colleagues and to report through the product team leadership. Statisticians in such an environment support only one compound, but remain with that product through its various stages of development including commercialization.
This presentation will discuss the product team concept in detail using examples from pilot product team programs at Lilly. Effects of the product team construct on teamwork, morale, product ownership, capacity planning, and career growth and development will be discussed. Advantages and disadvantages of the product team structure will be reviewed along with organizational and operational recommendations.
M.K. Srirama, Senior Directior of Biostatistcs, Kendle International Inc.
A CRO perspective
Jeff Schwartz, Pfizer Inc
Some Issues in running a international multi-site Biometrics Group in the Pharmaceutical Industry
Pfizer is a global pharmaceutical company that develops all of its products internationally. However, Pfizer has several locally managed sites as well as Biometrics groups at 3 different sites. Thus Pfizer has adopted a globally harmonized, locally managed approached to providing Biometrics support to its global project teams. We describe the structures and processes that accomplish this balance and list some hurdles that we had to overcome.