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 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 My experience is most relevant for people who want to consult on the side, rather than full time Im not going to discuss the business and financial aspects of statistical consulting Im 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? 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? 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? 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? 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 Solid statistical training Excellent oral and written communications Excellent oral and written communications Able to make and defend recommendations Able to make and defend recommendations Willing to extend oneself to meet deadlines Willing to extend oneself to meet deadlines Capable of fulfilling both basic and higher-order roles of a statistician 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 Design the statistical aspects of an experiment or study Collect and organize the data Collect and organize the data Analyze the data Analyze the data Report the results Report the results

6. Roles of a biostatistician Higher-Order: Collaborate on the conceptualization of the problem Collaborate on the conceptualization of the problem Define (refine) the scientific questions of interest Define (refine) the scientific questions of interest Ask the hard questions concerning the proposed study design Ask the hard questions concerning the proposed study design Initiate and lead discussions concerning analysis approaches and interpretation of results 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 Not enough to provide the correct answer to a design or analysis problem when asked Must be willing to: Must be willing to: Initiate a conversation Initiate a conversation Schedule and run a meeting Schedule and run a meeting Present new insight Present new insight Propose a possible revised solution Propose a possible revised solution Negotiate an acceptable approach rather than just provide the correct technical response to an inappropriately posed question 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) Network (both with statisticians and subject-matter specialists) Consider working with an established consultant Consider working with an established consultant Take advantage of every opportunity Take advantage of every opportunity Never say no to anything (initially) Never say no to anything (initially) Do outstanding work, no matter how small the opportunity seems 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) 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: The focus will more likely be on: General planning General planning Study design Study design Providing advice on analyses Providing advice on analyses Replicating analyses that others have completed Replicating analyses that others have completed Reviewing protocols, analysis plans, and reports 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 validate decisions that have already been made Someone who will find a positive result from a negative study Someone who will find a positive result from a negative study

11. How to be maximally satisfied as a consultant Dont be a hired gun Dont be a hired gun Dont be a rubber stamper Dont be a rubber stamper Strive to become a valued team member Strive to become a valued team member Find a company who will treat you like a valued employee even though you are not 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 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 deliver information our customers want and need We must improve decision making 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 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 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 learn new statistical methodology and how to apply it to a particular situation Ability to develop new methodology when standard methods are not applicable Ability to develop new methodology when standard methods are not applicable Knowledge of computer software for analyses and data management 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 Ability to see both the big picture and the technical details Leadership skills to supervise support staff Leadership skills to supervise support staff Leadership skills to direct and influence the scientific and statistical aspects of a project Leadership skills to direct and influence the scientific and statistical aspects of a project Communications skills 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) 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 … 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