1. Starting (and Succeeding) as an Independent Statistical Consultant Charles S. Davis, Ph.D. Elan Pharmaceuticals Roundtable Conference Call ASA Statistical Consulting Section

2. Introductory remarks • My focus is primarily on consulting for pharmaceutical/biotech companies • My experience is most relevant for people who want to consult “on the side”, rather than “full time” • I’m not going to discuss the business and financial aspects of statistical consulting

3. Outline • Is independent consulting a good option for me to consider? How do I decide? • I want to do statistical consulting (“on the side” or “full time”). How do I get started? • What are pharmaceutical/biotech companies looking for in an external stat consultant? What should they be looking for? • How can I best ensure that consulting will be challenging and fun, rather than tedious or mundane?

4. What type of person should consider statistical consulting? • Solid statistical training • Excellent oral and written communications • Able to make and defend recommendations • Willing to extend oneself to meet deadlines • Capable of fulfilling both “basic” and “higher-order” roles of a statistician

5. Roles of a biostatistician Basic: • Design the statistical aspects of an experiment or study • Collect and organize the data • Analyze the data • Report the results

6. Roles of a biostatistician “Higher-Order”: • Collaborate on the conceptualization of the problem • Define (refine) the scientific questions of interest • Ask the “hard questions” concerning the proposed study design • Initiate and lead discussions concerning analysis approaches and interpretation of results

7. Example (from DeMets et al, 1994) • Not enough to provide the correct answer to a design or analysis problem when asked • Must be willing to: • Initiate a conversation • Schedule and run a meeting • Present new insight • Propose a possible revised solution • Negotiate an acceptable approach rather than just provide the correct technical response to an inappropriately posed question

8. How do I get started? • Network (both with statisticians and subject-matter specialists) • Consider working with an established consultant • Take advantage of every opportunity • Never say “no” to anything (initially) • Do outstanding work, no matter how small the opportunity seems

9. What should pharma/biotech companies be looking for? • It may be difficult for a consultant to perform routine analyses and prepare reports (due to regulatory constraints on processes & procedures) • The focus will more likely be on: • General planning • Study design • Providing advice on analyses • Replicating analyses that others have completed • Reviewing protocols, analysis plans, and reports

10. What might companies be looking for? • Someone who will validate decisions that have already been made • Someone who will find a “positive” result from a “negative” study

11. How to be maximally satisfied as a consultant • Don’t be a “hired gun” • Don’t be a “rubber stamper” • Strive to become a valued team member • Find a company who will treat you like a valued employee even though you are not • Work with people who respect and appreciate good statisticians

12. What should statisticians do? • We must deliver information our customers want and need • We must improve decision making • We must judge ourselves by whether we actually do so, and not be satisfied merely by deriving a new formula Gillings (2000) JSM Presidential Invited Address

13. How do we get there? DeMets et al. (1994) describe characteristics of a desirable “product” of a biostat training program: • Broad knowledge of a wide range of statistical methods and theory • Ability to learn new statistical methodology and how to apply it to a particular situation • Ability to develop new methodology when standard methods are not applicable • Knowledge of computer software for analyses and data management

14. How do we get there? DeMets et al. (1994) also mention: • Ability to see both the big picture and the technical details • Leadership skills to supervise support staff • Leadership skills to direct and influence the scientific and statistical aspects of a project • Communications skills

15. Key for future success of statisticians • Ron Iman, 1994 ASA president, recently wrote an article “A View of the Future of Statistics” (AMSTAT News, Sept. 2003) • He concluded by commenting on the skill needed for success in the future …

16. Key for future success of statisticians “The ability to communicate effectively with our customers in the written and spoken word” “With such skills, our profession has an unlimited upside” “Without them we will never achieve our potential”