How Biostatisticians Work: The Real Work, Communication, and Getting Hired

How Biostatisticians Work: The Real Work, Communication, and Getting Hired

Statistics courses teach you to fit a Cox model. Nobody teaches you what the job is actually like once you are inside a company. This book fills that gap.

It follows two complete chains end to end. One is a clinical trial: protocol and SAP, database lock, SDTM, ADaM, TLF, QC, submission. The other is real-world data: feasibility pull, case definition, cohort funnel, confounding, propensity scores, delivery to the investigator. Three running cases - the 420-subject phase III trial LUMINA-3, the 6,000-patient PRISM-HTN cohort, and BEACON-SM, which finds 92 patients among 4.18 million members - carry the same subjects, the same data and the same numbering from Chapter 1 to Chapter 16.

Alongside the technical craft, the book gives equal room to the things rarely written down: reading a SAP and a programming spec, explaining results to people who do not work with data, leaving an audit trail in a regulated environment, building a portfolio, interviewing, and what the first year is really like.

All code is SAS - 118 programs, executed end to end on SAS OnDemand for Academics, with the output checked cell by cell against every table printed in the book. Fifty-six CSV datasets and a paste-and-run edition of the code ship with it, so readers can reproduce every number themselves. More than a hundred PITFALL boxes record the ways this work actually fails.

Written for students heading into the field, career changers from mathematics, computing, biology or medicine, and new hires who can see only their own small square of the process. All data and cases are original fiction.

500 pages, with a glossary, a SAS quick reference, a guide to regulatory sources, and worked spec and shell examples.