Kammerman Consulting

WHAT I DO: I help pharmaceutical & biotech companies achieve FDA regulatory success by leveraging my statistical expertise & deep industry knowledge from almost 30 years of experience working with the FDA and AstraZeneca. WHAT MAKES ME UNIQUE: With 30 years as an FDA Master Statistical Reviewer & industry expertise, I offer a rare advantage: insider knowledge of FDA’s expectations & the industry know-how to deliver. I help clients navigate challenges, optimize strategies, & achieve regulatory success with confidence. I also specialize in the clinical studies section of labeling, identifying potential issues & proposing alternative content. CLIENT OUTCOMES: Successful FDA Approvals ⏱ Reduced Regulatory Review Timelines Improved Submission Quality & Clarity Prepared for FDA Concerns & Expectations WHAT OTHERS SAY: ”Dr. Kammerman is an extremely accomplished biostatistician who incorporates clinical & regulatory perspectives in her advice on clinical study designs & analyses. She is also very patient-centric & has been pioneering novel approaches in clinical trial designs as well as clinical endpoint selections that incorporate patient reported outcomes (PROs) to determine the clinical meaningfulness of the endpoints. She is innovative in her statistical hypothesis testing principles & has helped develop PRO-based analysis plans to augment the clinical endpoints.” - Dr. Pravin Chaturvedi WHO I WORK WITH: Pharma/Biotech CEOs & CMOs Biostatistics VPs, Executives, & Clinicians Regulatory Affairs Specialists SERVICES I PROVIDE: 🧪 Biostatistical Consulting for FDA Submissions Study Design Patient-Reported Outcomes (PRO) Expertise High Level Regulatory Review of FDA Submissions CHALLENGES MY CLIENTS FACE: 🤷 Limited In-House Biostatistics Expertise Achieving Successful Regulatory Outcomes 🧬 Biostatistics Regulatory Strategy Website URL: