Odin PressAn independent publisher and book-production studio.
Ingrid Voss is a senior biostatistician (ret.) and independent regulatory consultant who spent thirty-one years in the pharmaceutical industry — twelve at a mid-cap East Coast oncology developer, fourteen as Senior Director and then Vice President of Biostatistics at a top-twenty pharma, and the last five advising small- and mid-cap sponsors on adaptive designs, estimands, and external controls.
She holds a PhD in biostatistics from the Karolinska Institute, has been the sign-off statistician on roughly four hundred clinical trials, and has negotiated more FDA Type C meetings than she cares to count.
Her opinion, formed across three decades of post-hoc protocol reviews: the operating-characteristics table is the only document that survives a regulator interaction unchanged, so it should be written first. Most "missing data" problems are estimand problems wearing a missing-data mask.