Home » Additional Features

Cultivating a Culture of Collaboration (with Gusto) in Your Career

1 May 2017 One Comment

With more than 400 publications and at least twice as many conference presentations, Joseph C. Cappelleri is a prolific author and medical researcher in the pharmaceutical industry. He is a senior director of biostatistics at Pfizer Inc.

You’ve attributed your professional success to developing a reputation for cultivating a culture of collaboration. How have you done this, and what advice do you have for young professionals to do so?

My resource, or “secret sauce,” for cultivating a culture of collaboration begins with taking ownership of myself. By continuing to learn and relearn, and building on my academic training, I have empowered and trained myself to relish and, in some cases, master whatever set of skills was being sought for its own intrinsic value—especially skills related to biopharmaceutical research.

The second ingredient in the special sauce of collaboration is to share a newly acquired knowledge or idea with others who have a common interest and stand to benefit. That means I have something of potential value to offer and engage other colleagues—be it a statistical method, novel application, methodological nuance, research or strategic idea, or something else.

The third factor, which combines self-interest and common interest, involves merging the other two factors to achieve a synergistic elevation and refinement of the research endeavor by capitalizing on each other’s strengths to fortify the endeavor more than it would have been individually. In doing so, actively seek out collaborators with special talents or knowledge and give them something in return that has professional value to them. Choose a regular collaborator and bring out the best in each other.

My advice to young professionals, therefore, is to follow this recipe: Build your skill set unconditionally and regularly, share it with colleagues who share a common interest, and work together to make the summed contribution greater than its individual parts.

Beyond developing the reputation of someone to engage as a collaborator, what advice do you have for being a successful 21st-century statistician?

The successful 21st-century statistician needs to develop and refine first-rate quantitative skills through dedication, habitual study, and regular practice. Technical preparation is required through competency in general areas and mastery in particular areas. Substance reigns with precision and correctness as the hallmarks of analytical virtue.

That said, being technically smart is—to use a statistical phrase—a necessary but not sufficient condition. Strong and persuasive communication skills, especially to colleagues not versed in the language of statistics, is paramount regarding the methodological strengths and weaknesses of a particular strategy or position.

The influential 21st-century pharmaceutical statistician needs to understand the broad clinical, regulatory, and public health context. By being proactive with up-to-date knowledge, the pharmaceutical statistician can provide team members with strategic directives—which he or she is encouraged to originate and propose—and with guidance about design options and their tradeoffs, execution regarding quality control and risk mitigation, analytic strategies including their strengths and weaknesses, and effective interpretation of results. Having an intrinsic passion for statistical science, along with knowledge of the subject matter to which it is applied, builds a natural momentum toward co-authoring manuscripts and conference presentations on applied and methodological topics. And with that comes respect from others that opens the pathway for even more collaborative and authorship opportunities.

In the 21st century, a pharmaceutical statistician who continually learns technical and nontechnical aspects of his or her business will be in a favorable position to make a positive difference. Then the “magic” happens: sharing these learnings so as to redound benefit to individual team members. Such a statistician, therefore, is rendering value not only by providing his or her expertise, but also by elevating the work of others so they contribute more to a project than they would have otherwise. Bring out the best in others.

Your advice for professional success could be applied to many career tracks. What do you like about working in the pharmaceutical industry, and what advice do you have for students considering this sector?

The nature of the pharmaceutical industry—with a premium placed on ongoing innovation and research aimed at optimal patient care—makes it stimulating, rewarding, and challenging. I welcome the internal and external challenges that fuel stimulation and reward. I embrace the expectation to challenge myself to work with others in the most efficient manner and to adapt effectively in an evolving and competitive environment. This expectation motivates me to elevate myself to be the best medical researcher possible because the ultimate objective and reward transcends personal ambition and has much higher stakes: It is about improving the quality and quantity of life for millions and millions of patients worldwide, and to do so with integrity, honor, and distinction.

I am fortunate and blessed to be part of a company and an industry that embodies the core values of collaboration, community, customer focus, innovation, integrity, leadership, performance, quality, and respect for people. These values are required for a company to have sustained, long-term success in the industry. I embrace them and find them ennobling; they enrich the human spirit and condition.

My advice to students of statistics who wish to enter the pharmaceutical industry is multifold. First, there is no substitute for mastery of content. Be the real deal. Others will soon realize and appreciate your passion and expertise. It is the way we are wired. Such mastery requires the virtues of working industriously and consistently that open gates to technical creativity, implementation, and opportunities. Repetition is the mother of skills and all learning: practice, practice, practice—here that old-fashioned work ethic, tried and true, kicks in Mastery for statisticians in a given disease area requires a good understanding of it, which makes the statistics more pertinent and the disease area more relevant as the two disciplines feed on each other.

Second, in addition to developing a strong foundation in general and common areas of statistics, students should specialize in at least one area based on their passion for the subject while taking into account the demand and supply of talent in that subject. Seek out specialized areas where there is much demand yet low supply of talent (or at least where demand exceeds supply), especially on the quantitative side, and fill that void with gusto. And then bring out the best talent in others by seeking them out as partners, be they a fellow statistician or clinician, programmer, data manager, or some other professional. Do this unconditionally and, perhaps, they may even bring out the best in you. After all, statistics is a collaborative science.

Third, as a personal strategy, students should be life-long learners of not only statistical and data science, but also nonstatistical knowledge and organizational principles. Broadening nonstatistical knowledge involves adroitness in business conduct helpful to the industry statistician such as developing skills in consulting, communication (presentation and writing), influence, career planning, personality training, and team building. These skills fortify a winning culture at work.

In addition, expansion to fields seemingly unrelated to statistics—such as travel, music, sports—and reading good books on history, literature, art, and other disciplines are encouraged as they stimulate a person to be more interesting and engaging with an open mind to see things from multicolored perspectives. Perhaps the determination and strategy observed or experienced during a sporting event, or an elegantly written passage of a historical event, may inspire an analogous strategy or interpretation that helps resolve or refine a statistical inquiry for a pharmaceutical application. One resource that cultivates a personal strategy of life-long learning is The Great Courses.

Fourth, living and practicing a positive attitude about ourselves, others, and life in general has a way to propel higher, more cultivated thought. Live in a state of gratitude and appreciation. The pharmaceutical industry welcomes a can-do, confident attitude full of optimism and farsightedness.

Fifth, I would encourage students to join a professional organization and become actively engaged in it by volunteering, identifying with it, and taking advantage of its rich and expansive opportunities; for example, the American Statistical Association is a gold mine for statistics education and other professional opportunities. Joining the right eclectic organization, like the ASA, provides its members with wide-ranging possibilities around the different facets of statistical and data science, propelled by a diverse stream of geographic representation and scholastic interests. The benefit received from professional growth and development through such organizations is proportional to the time and effort made to them.

Sixth, start networking. A corollary of actively contributing to a professional organization is the networking opportunities provided. Networking provides an opportunity for statisticians to have more impact on a larger scale, accomplish goals sooner or more efficiently, and obtain an intrinsic sense of belonging. While virtual interactions among colleagues are welcomed and worthwhile, face-to-face human interactions are even better in identifying and connecting with people and a common cause. Networking is also a forum for building character and contributing one’s voice, as a stage for participants to earn respect and trust by sharing information and bestowing good will.

Seventh, develop leadership qualities and lead by action—walk your talk. Leadership qualities have multiple facets. Some are majoring in major things and letting go of the small stuff; having a respect for diversity and openness to different opinions; being willing to see things as they are, not as what we wish them to be; having the wisdom to discern when to get involved and when not to; and having a healthy appreciation for creativity and innovation.

Finally, elevate yourself through role models and mentors. Doing so can be ennobling and will save time and effort in achieving many objectives. Different role models and mentors may serve different purposes. They can come from multiple sources such as home, college, work, and the ASA. Ideally, while personal interaction with a mentor is expected, personal interaction with a role model is preferred. But the beneficiary does not necessary have to personally know a role model to achieve the intended objective. The sheer embodiment of a role model—through his or her authored works, presentations, and positions—may be sufficient to inspire the beneficiary to succeed as intended. Not only can the right individuals inspire and enhance your craft, programs or organizations of excellence can be uplifting as well.

How has the role of a statistician in pharmaceutics evolved since you started at Pfizer in 1996? What do you see as the future for statisticians in pharmaceutics?

Beginning with the U.S. Kefauver Harris Amendment in 1962, FDA hired statisticians to help with the review and approval of new drugs. Consequently, statisticians were hired in the pharmaceutical industry to provide what was needed for regulatory approval. Until around 1990, their role was limited. Statistical input was generally restricted to what was deemed necessary, with little or no involvement elsewhere. In the 1970s, however, the FDA’s Robert T. O’Neill made huge contributions to promote clinical, as well as nonclinical, development and statistical rigor within FDA. This trend then permeated the industry and the situation started to change.

Since the early 1990s, the role of statisticians in the pharmaceutical industry—especially those employed by larger companies—has evolved and become more elevated with the advent of the statistical analysis plan and Statistical Principles for Clinical Trials (International Conference on Harmonisation E9: ICH-E9). In the mid-1950s, there was little use of statistics, but—as time moved forward—the role of clinical statistics progressed from being merely a formal requirement to one having tactical use. Since around the beginning of the 21st century, the role of statistician has expanded to include the strategic use of statistics and the craft of statistical thinking. Thus, clinical statistics has come a long way in supporting development of medicinal products for regulatory approval and beyond when long-term effects of new drugs are identified and evaluated in a larger population or subpopulation.

The statistician’s role has advanced to a full and equal partner with basic, clinical, and regulatory scientists, as ordained in ICH-E9, and I expect this role to continue. I also expect statisticians to continue their focus as consultants in different areas of pharmaceutical research and development, as well as to be gatekeepers in experimental design and analysis.

The application of statistical thinking and quantitative decision-making will continue to permeate throughout the life cycle of pharmaceutical product. The companies that thrive will recognize that statistics is the heart of medical research. Major topics of interest in the pharmaceutical industry are those presented at the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, including (but not limited to) benefit-risk assessment, biosimiliars, and patient-reported outcomes.

As parallel progress is made in related areas such as genomics, epidemiology, and risk management, even more opportunities will exist for the statistician to contribute and collaborate (see, for example, a recent posting in the Biopharmaceutical Report from the ASA Biopharmaceutical Section).

In social settings, we understand that, when asked what you do, you say you are a medical researcher. Why do you do this, and how do you still convey your pride about being a statistician?

Statistics is, in my opinion, the center of research and the most sacred of the sciences. For the past 24 years (21 in the pharmaceutical industry, three in academe), I have been fully committed and wholly engaged with clinical applications intended to improve the quality of life and health status of millions and millions of patients worldwide. For example, I have been fortunate to have made instrumental contributions to regulatory approval or subsequent medical triumphs of successful Pfizer medicines such as Viagra for erectile dysfunction, Chantix for smoking cessation, Lyrica for fibromyalgia and neuropathic pain, Geodon for schizophrenia, and Sutent for renal cell cancer.

Over the years, my role has involved primarily the design, measurement, validation, analysis, and interpretation of health measurement scales where I have blended the statistics disciplines of biostatistics and psychometrics. Another passion of mine has been in methods and applications of meta-analysis in medical research. As a result of numerous co-authored publications and conference presentations on medical topics, it is only befitting to say I am a medical researcher. And one with gusto!

Medicine is the science and practice of the diagnosis, treatment, and prevention of disease. The medical profession has many specializations and sub-specializations grouped into certain branches of medicine. Every physician is educated and trained in the basic sciences of medicine. Some groups of physicians, such as primary care physicians, are considered general health care providers, while others specialize in particular fields of internal medicine such as cardiology, urology, and oncology.

By analogy, a statistician is typically trained and educated broadly in the statistical sciences by taking core courses in a college program in statistics or related discipline. Some statisticians remain generalists and provide a diverse mix of services or consult with other statisticians who specialize in a particular area of application or theory. These other statisticians spend more time delving into particular branches of statistics such as biometrics, econometrics, and psychometrics.

Statisticians in the pharmaceutical industry recognize their purpose is to provide new important medicines of the highest quality to patients as quickly, efficiently, and safely as possible. Doing so requires a first-rate operating model with related disciplines in drug development, including data management, statistical programming, regulatory, pharmacology, and clinical. The foundation of this developmental infrastructure emphasizes being both efficient and effective, getting things right the first time, having the right people in the right roles, and taking full ownership of data.

This agile model also strives for greater clarity, accountability, and cost efficiencies; promotes reduced organizational complexity; and embraces innovation and new technologies that leverage deep expertise and broad capabilities. By interweaving a seamless end-to-end approach across all disciplines within a development organization, quality and efficiency of clinical trials become a reality and the patients who benefit from the medicines are best served.

1 Star2 Stars3 Stars4 Stars5 Stars (No Ratings Yet)

One Comment »

  • beauty said:


    Cultivating a Culture of Collaboration (with Gusto) in Your Career | Amstat News