Nonclinical Statistics Book

Springer has a new book (Amazon) edited by Lanju Zhang that captures the breadth of problems for statistics in the pharmaceutical industry including: compound optimization, genetic testing, high-throughput screening, safety testing, and manufacturing. From the first chapter:

'We define “Nonclinical Statistics” as statistics applied to areas other than clinical trials in pharmaceutical/biotechnology industries'

It's a big book (~700 pages) and has a lot of great content. I was a section editor for the drug discovery chapters:

• Statistical Methods for Drug Discovery (Max Kuhn, Phillip Yates, and Craig Hyde)
• High-Throughput Screening Data Analysis (Hanspeter Gubler)
• Quantitative-Structure Activity Relationship Modeling and Cheminformatics (Max Kuhn)
• GWAS for Drug Discovery (Yang Lu, Katherine Perez-Morera and Rita M. Cantor)
• Statistical Applications in Design and Analysis of In Vitro Safety Screening Assays (Lei Shu, Gary Gintant and Lanju Zhang)

I particularly like the chapter by Bill Pikounis and Luc Bijnens ("How To Be a Good Nonclinical Statistician") which has a lot of excellent general advice.

The back cover blurb is:

'This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.'

The hardcopy format will be released on February 14, 2016. I couldn't say whether you should gift the important person in your life with nonclinical statistics...

Nonclinical Statistician Position at Pfizer

The Research Statistics group collaborates across a wide variety of activities in the early phases of drug discovery. This position is located in Groton CT and has a focus on the optimization of chemical matter and the development of assays to characterize these molecules

The successful candidate will:

• Demonstrate leadership in influencing and improving drug discovery by identifying, developing, and applying new quantitative methods.
• Proactively seek collaborations with scientists and lab heads.
• Collaborate with scientists to plan meaningful studies, statistically analyze, and communicate / document the results.

Requirements:

• M.S. or Ph.D. in Statistics, Biostatistics, or related field and 2+ years statistical consulting experience in drug discovery and development, preferably in a laboratory science environment.
• The ability to proactively seek collaborations with scientists and lab heads.
• Strong initiative, excellent interpersonal and communication (written and verbal) skills
• Understanding of inference and probability; competence in contemporary linear modeling including mixed models, nonlinear regression; and predictive modeling/machine learning.
• Solid understanding of experimental design
• An understanding of tools for the analysis of high dimensional data
• Strong computational skills in R

Desired:

• Five or more years experience in the pharmaceutical industry.
• Sound understanding and experience of applying Bayesian methods
• Formal training in, or thorough understanding of: human physiology, cell biology, pharmacokinetics and/or pharmaceutical chemistry.
• Strong computing skills in scripting languages, such as perl, python, unix shell scripts or others. SQL and LaTeX skills are also advantageous.

Applying

The position is posted at http://pfizercareers.com/

• Go to "Search jobs" on the green tab
• Choose "SEARCH and APPLY for Jobs"
• In the "Advanced Search" bar, search on Job Id 1024297