How To Be a Good Nonclinical Statistician




© Springer International Publishing Switzerland 2016
Lanju Zhang (ed.)Nonclinical Statistics for Pharmaceutical and Biotechnology IndustriesStatistics for Biology and Health10.1007/978-3-319-23558-5_3


3. How To Be a Good Nonclinical Statistician



Bill Pikounis  and Luc Bijnens2


(1)
Janssen Research and Development, Johnson & Johnson, Spring House, PA, USA

(2)
Janssen Research and Development, Johnson & Johnson, Beerse, Belgium

 



 

Bill Pikounis



Abstract

All fields profess commonly expressed criteria for its individual professionals to be successful. For the pharmaceutical/biotechnology industry that is the scope of this book, there are many accounts in the field of statistics of what it takes to be a good statistician. The goal of this chapter is to focus on specific characteristics for nonclinical statisticians which we believe are essential to be viewed as “good” professionals, either as individual contributors or managers.


Keywords
AdaptabilityCollaborationConsultationEnterprise PerspectiveNegotiationResourcingStatistical Software



3.1 Introduction


Many books, articles, and web content have been published that at least partially consider the concept of how to be a good statistician. See for example, Hahn and Doganaksoy (2011) and references therein. Our goal for this chapter is to focus on behaviors that we believe define good nonclinical statisticians.

Our content will be broad and lack concreteness in places due to the overview nature of the topic. We do hope to provide at least high-level practical advice and references for further study from our personal experiences, and therefore use a mix of first, second, and third person perspectives to the reader.

Our views are based on a combination of over 35 years as nonclinical statisticians in the pharmaceutical industry. We lead groups in the United States and Europe, and our scopes of responsibilities and accountabilities are global. There is no official definition of “nonclinical”, and please see Chap. 1 and other chapters in this book for examples of the span of nonclinical. For this chapter, we presume three general areas outside of clinical trials: discovery, manufacturing, and safety. Each of these three general areas also contains multiple other broad areas, of course, and we will touch on some of these in more specific descriptions. Whatever your definition of nonclinical statistics is and its areas of application, we believe that we have had similar experiences within our company.

There will be two main sections in addressing what makes a good nonclinical statistician. The first is common to all who identify themselves, or are identified, as a nonclinical statistician. We refer to this role as an individual contributor. The second section covers the additional duties of managing and leading a nonclinical statistics group, which we will refer to as manager. There is overlap to the principles in both roles, but we feel there are strategic factors of the manager role which are specific for success of nonclinical groups within their larger organization.

While we both feel our years of experiences and the people networks we have built as nonclinical statisticians provide us with meaningful perspectives to write this chapter, we do know we could have missed important points, or provided points where other nonclinical statisticians disagree. Our chosen criteria of what is “good” as a nonclinical statistician may be incomplete or disagreeable to you as a reader. We certainly invite you to contact us with any thoughts to help us clarify and learn about other factors you feel produce a good nonclinical statistician.


3.2 Individual Contributor



3.2.1 End-to-End Responsibility for Projects


In contrast to clinical development studies and trials within the pharmaceutical/biotechnology industry, there are generally no requirements for nonclinical statisticians to be consulted or to be part of the team for design or data evaluation of studies or experiments. When a scientist, engineer, or researcher wishes or is asked to enlist the help of a statistician for a nonclinical need, there is an initial contact.


3.2.1.1 The Initial Request


These initial, “request for help” contacts are variable in their frequency, like an inhomogeneous Poisson process. They are also variable in urgency, importance, complexity, and familiarity. The requestor may be someone you have never worked with before. Or it may be someone you have been actively collaborating with.

It is critical for a good nonclinical statistician to make no assumptions about the request or the requestor before a first meeting is held. It is certainly tempting to worry about yet another unplanned challenge that will add stress to an already heavy workload. But there is always the opportunity to start or continue building a relationship, valuably contribute to an important scientific or business endeavor, or expand your knowledge and skills.

No requests for help should ever be turned down. After a request comes in, it needs to be dealt with in a timely manner. Our policy experience is to respond within the next business day. This results in a maximum of 2 full business days, given the modern nature of global time zones and 24/7 connectivity. The initial response may be no more than an acknowledgment that the request has been received, reviewed, and will be dealt with soon.

The minimum obligation is to provide an initial consultation, which invariably means one hour or less. Within our large company, requests occasionally come to us from outside our official scope of nonclinical pharmaceutical research and development, due to network and reputation. We owe it to our company, and as statistics professionals, to properly perceive and understand the need of the requestor without pre-judgment. Then a healthy dialogue can take place to come up with options which may or may not involve continued collaboration with a nonclinical statistician from the staff.


3.2.1.2 The Initial Consultation


A request as previously described will typically turn into a project. Our definition of “project” here is that at least one more action needs to be taken beyond the initial consultation to fulfill this request and declare it as completed (Allen 2002). This determination of a project comes at the end of the initial consultation. One can optionally declare the actual discussion of the initial consultation as a project, if no further tasks are defined and agreed to for the nonclinical statistician to execute. If tasks for further collaboration are agreed to, the nonclinical statistician should proceed with defining and managing a project or projects within their organization system, stemming from the request. Projects can range to days to weeks to months to years.

We recommend an initial request be followed-up with a sincere desire to meet with a person and understand the entire context of the statistical needs. As mentioned earlier, this necessary level of understanding is impossible from an email or other communication channels. Except for rare, straightforward cases, such as explaining the difference between a standard deviation and standard error, replying to an email with a solution that you believe answers the question must be avoided. (Another category of exception is document reviews.) The prospective collaborator may believe their request is a simple question or questions, but virtually always it is not. All this can be clarified with an initial consultation. If the initial consultation can feasibly take place face-to-face, it should, especially for new or early relationships. In our modern world, this is not always possible due to geographical or time constraints.

The professionalism of a nonclinical statistician will start to reveal itself immediately to a requestor in how they handle the request and proceed to the initial consultation. As the saying goes, “first impressions count”, whether fair or not. Use phrases on behalf of yourself or your organization such as:



  • “Thank you for reaching out.”


  • “I/We will be glad to help.”


  • “May I suggest we set up a day/time for an initial consultation so I can fully understand your data, objectives, and scientific and business contexts?”


  • “If you have any data or background materials you can provide beforehand, please email them to me.”

None of these phrases commit you to any obligations beyond the initial consultation. Even if they do provide background materials, you may not have the time to do more than glance at them, which is fine since they will not provide all the information you need. Your genuine interest will also be clearer to the requestor if you take the initiative to set up the appointment time and location that makes it convenient for them.

When you meet, allow your requestor and (potential) collaborator to provide all the necessary information in order to understand what is needed. Strive for a good conversation and healthy dialogue at all times. There are boundless references on how to do this, especially for the “listen first” and “seek first to understand” (Covey 1989) stages. It is easier said than done, of course, but this constant attunement is critical to the quality of the relationship.

The researcher requestor may not have a clear idea of how statistics can help. A key charge for the nonclinical statistician is to translate the scientific questions into statistical frameworks such as (but not only!) hypothesis testing or interval estimation, whether the request involves data at hand or involves the planning of a study. Key technical pieces involve understanding of experimental units, factors, endpoints, design, missing data, excluded data, etc. Appreciation and understanding of the underlying science is needed as well, since later evaluation and the quality of the interpretation of the data depends on it. The rest of this book offers a comprehensive canvas of the diversity of research & development areas where a nonclinical statistician can help. Good general traits for the consultation aspects of statistician can be found for example in Boen and Zahn (1982) or within Hahn and Doganaksoy (2011).

The researcher may have already completed some analysis of the data and seeks your review or your assistance with misunderstanding or limitations of the software. This is increasingly common due to the wide availability of software for storing and analysis of data. In projects that involve big data, collaboration with other quantitatively trained colleagues is essential. For now, we mention that open receptiveness to ideas about statistical methods and data analysis methods is essential. If the initial consultation reveals that the project will be a more 1-to-1 or 1-to-small-group collaboration, the nonclinical statistician will have dominant control of the choice of statistical methods. If the nonclinical statistician is part of an interdisciplinary team with other quantitative colleagues, then confidence, but not arrogance, is needed to mutually choose appropriate data analytic techniques. Depending on experience and the complexity of the problem, one might find themselves unsure at all what statistical methods will be needed. It is perfectly all right to say “I don’t know” or that “I don’t have experience,” and also assure your requestor that you have the ability to search for accurate and sensitive approaches from literature, colleagues, etc..

Completion of the initial consultation requires a clear definition of what is needed and when it is needed, particularly if an urgent business milestone is approaching. Here is where good negotiation skills on part of the nonclinical statistician are a must. Besides the people present in the initial consultation meeting, there are other considerations of stakeholders that are not present that will be taken into account, and these must be disclosed. It may be that a presentation to management is coming up next week and one or a few slides of statistical content are needed to cover evaluations and interpretations of a key endpoint. A more comprehensive report can wait until later, or eventually may not be needed at all. Everyone is busy, and we have found universal recognition by researcher colleagues that the ideal situation of fast as possible delivery of results and perfect work is not attainable. One solution may turn out to be for the nonclinical statistician to serve as an advisor for the researcher to continue doing their own analysis with their own software package. As Allen (2002) describes, every project can always be done better with more time and/or information. Allen furthermore advises, and we paraphrase here: “Lack of time is not the major issue. The real problem is a lack of clarity and definition about the project and what is required.”

One more topic we wish to mention here is the “curse of knowledge,” and its effect on interactions, starting with the initial consultation. As Heath and Heath (2007) discuss, “once we know something, we find it hard to imagine what it was like not to know it.” As with all professional fields, constant self-checking of this natural human tendency is needed in order to prevent obstacles in communication by a nonclinical statistician to a non-statistician. Statistical jargon will be needed when a statistical expert verbally discusses, writes, or presents statistical concepts related to problems and solutions. Awareness to simplify as much as possible with the listener’s perspective in mind will be beneficial to effectively communicate complexity and to build credibility. Practice of this behavior is needed all the way through and to the end of the project in order to continue reception of its benefit.


3.2.1.3 Lead Responsibility to Complete the Project


The initial consultation also unequivocally identifies the lead nonclinical statistician contact for the project. Usually this is the statistician who assumes the lead for the initial consultation in the first place. Exceptions to this would include professionals in the early stage of their nonclinical statistics career, where a more senior colleague will assist. In more complicated, longer term projects, this lead statistician may also need to coordinate with other nonclinical statisticians to perform portions of the work. We feel the taking on of full professional responsibility and accountability for a project is a vital component of the nonclinical statistician who is identified as the lead. It is an end-to-end endeavor.


Prioritization

The demand of choices on how to spend time on one project in relation to all others requires daily assessment. Every collaborator believes their project is important and wishes for their project to be attended to as soon as possible. Regulatory and business critical needs related to your company’s portfolio of medicines should also take precedence. If this is not clear, your supervisor or line management should be able to clarify for you. In addition to these external forces, it can be helpful to ensure you do not only do work as it shows up, but also to dedicate time to defining your work, and to dedicate time to doing that predefined work (Allen 2002). Self and time management are universal problems in today’s fast-paced world, so seeking out a personal organization system that you can execute will be advantageous.


Data Transfer

The lead nonclinical statistician will need to work with the data directly in whatever form it comes in. Excel spreadsheets and other tabular formats specific to software remain most common across discovery and manufacturing areas. The transfer of data via structured queries (SQL) from standard relational database systems remains infrequent. It is reasonable to request data of certain format from a requestor, keeping in mind the tradeoffs of the time it requires, the building of the relationship, and the business needs. If you can find a format where additional processing by your statistical software can reshape or transform the original data into formats for the needed statistical functions or procedures, proceed with that.

One example of this is the wide format for longitudinal data, where each experimental unit is a separate row, into the long and narrow format of one observation per row for standard modeling syntax of SAS or R. Another is the combination of different endpoints or factor levels across different worksheets or tables, to potentially merge into larger tabular data sets in preparation for exploration and modeling.

It is always best to ask if a machine readable format can be produced, especially if a PDF, or word-processing document, or even paper hardcopy of the data is initially provided. The delay and risk of a bad outcome from re-entering data always outweighs the additional work to avoid such intractable formats. If data transfer and data management remain an issue after reasonable negotiation, be clear that delays due to needed manual entry or copy and pasting, and careful verification, will be substantial. This can be acutely painful when compliance and regulatory procedures and expectations are added, and reviews, approvals, and signoffs are needed.
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Jul 22, 2016 | Posted by in PHARMACY | Comments Off on How To Be a Good Nonclinical Statistician

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