Brett J. Peterson, MS

Brett Peterson has more than 25 years of clinical research experience, including 20 years dedicated specifically to medical device development. As Senior Principal Biostatistician at NAMSA, Brett partners with clients to deliver strategic statistical solutions that accelerate regulatory approvals and optimize clinical outcomes. His expertise spans study design, statistical analysis planning and execution, reporting, publishing, and advanced programming in SAS and R, ensuring robust, compliant data for global submissions.

Brett has supported a wide range of global regulatory pathways, including PMA, 510(k), clinical evaluation reports, and post-market studies, and is highly skilled in developing statistical analysis plans, managing data collection, and preparing reports for regulatory authorities and data safety monitoring boards (DSMBs). He collaborates closely with cross-functional teams and steering committees to translate complex data into actionable insights, helping clients navigate challenging regulatory landscapes with confidence. His therapeutic experience includes neurology, cardiology, urology, oncology, gynecology, endocrinology, ophthalmology, peripheral artery disease, and wound care, with a proven track record in both human and animal studies.

Brett has a passion for quality, leading a Global Publications Excellence Initiative, serving on a Standard Operating Procedures (SOP) Board, Scientific Advisory Committee and Global Evidence Team, and presenting at the NAMSA external webinar titled “How to Manage Clinical Study Data During COVID-19”. He received a best contributed paper award at the SAS User’s Group International conference, presented on Publishing Evidence for Global Audiences at the Winter Device Congress in Japan, and has co-authored over 30 peer-reviewed manuscripts.

Before joining NAMSA in 2020, Brett held senior roles at Medtronic and Mayo Clinic in statistical programming, statistical programming leadership, clinical study management, biostatistics, and publication development, providing a wide breadth of clinical research perspectives and a well-rounded skillset.  He earned his MS in Biostatistics and BS in Statistics from the University of Minnesota.

CORE COMPETENCIES

• Statistical analysis planning, execution, and interpretation
• Statistical programming development and validation using SAS and R to analyze data and create tables, listings, and figures for submissions, reports, publications, and other needs
• Co-author and support study reports
• Support publications including co-authoring abstracts and peer-reviewed manuscripts
• Study design and execution
• Randomized, cohort, case-control, and observational study experience
• Animal study experience
• Feasibility and pilot study experience
• Pre-market approval, 510(k), and post-market study support
• Review and support protocol and case report form development
• Data collection development and management
• Communicate study plans and analysis results to various audiences
• Presenting at conferences and other venues
• Working with cross-functional teams including study teams and steering, publication, and data monitoring committees
• Perform analysis for clinical evaluation report safety and performance evaluations

RECENT PROJECTS

• Developed Statistical Analysis Plans and the tables, listings, and figures for two glaucoma management device feasibility studies in preparation for an IDE pivotal study submission to the FDA.
• Provided statistical support through 510(k) FDA submission for a device that treats stress urinary continence. Approval was received.
• Provided sample size calculations, protocol development, and analysis plan for high-quality (level 4) post-market clinical follow-up survey for a bone graft material intended for dental use, where the goal is to gather real-world evidence on safety and performance for clinical evaluation reporting.
• Supported clinical study result submissions to Chinese and Japanese regulatory bodies for a device that treats peripheral artery disease.

PUBLICATIONS

• Halling KC, French AJ, McDonnell SK, Burgart LJ, Schaid DJ, Peterson BJ, Moon-Tasson L, Sargent DJ, O’Connell MJ, Witzig TE, Farr GH, Thibodeau SN:  Clinical Significance of Microsatellite Instability and Allelic Imbalance of 8p in Stage B2 and C Colorectal Cancer:  Journal of the National Cancer Institute, Vol. 91, No. 15, August 1999, pp. 1295-1303.
• Berry R, Schaid DJ, Smith JR, French AJ, Schroeder JJ, McDonnell SK, Peterson BJ, Wang ZY, Carpten JD, Roberts SG, Tester DJ, Blute ML, Trent JM, Thibodeau SN:  Linkage analyses at the chromosome 1 loci 1q24-25 (HPC1), 1q42.2-43 (PCAP), and 1p36 (CAPB) in hereditary prostate cancer families:  The American Journal of Human Genetics, Vol. 66, No. 2, February 2000, pp. 539-546.
• Xu J, International Consortium for Prostate Cancer Genetics which includes the ACTAN Group, BC/CA/HI Group, Fred Hutchinson Group, Johns Hopkins Group, Michigan Group, Stanford Group, Tampere Group, Umea Group, Utah Group, Mayo Clinic Group:  Schaid DJ, McDonnell SK, Berry R, Schroeder JJ, French AJ, Peterson BJ, Blute ML, Thibodeau SN:  Combined Analysis of Hereditary Prostate Cancer Linkage to 1q24-25: Results from 772 Hereditary Prostate Cancer Families from the International Consortium for Prostate Cancer Genetics:  The American Journal of Human Genetics, Vol. 66, No. 3, March 2000.
• Berry R, Schroeder JJ, French AJ, McDonnell SK, Peterson BJ, Cunningham JM, Thibodeau SN, Schaid DJ:  Evidence for a Prostate Cancer Susceptibility Locus on Chromosome 20:  The American Journal of Human Genetics, Vol. 67, No. 1, July 2000, pp. 82-91.
• Shiba M, Bower JH, Maraganore DM, McDonnell SK, Peterson BJ, Ahlskog JE, Schaid DJ, Rocca WA:  Anxiety Disorders and Depressive Disorders Preceding Parkinson’s Disease: A Case-Control Study:  Movement Disorders, Vol. 15, No. 4, July 2000, pp. 669-677.
• Benedetti MD, Bower JH, Maraganore DM, McDonnell SK, Peterson BJ, Ahlskog JE, Schaid DJ, Rocca WA:  Smoking, Alcohol, and Coffee Consumption Preceding Parkinson’s Disease: A Case-control Study:  Neurology, Vol. 55, November 2000, pp. 1350-1358.
• Bock CH, Cunningham JM, McDonnell SK, Schaid DJ, Peterson BJ, Pavlic RJ, Schroeder JJ, Klein J, French AJ, Marks A, Thibodeau SN, Lange EM, Cooney KA:  Analysis of the Prostate Cancer-Susceptibility Locus HPC20 in 172 Families Affected by Prostate Cancer:  The American Journal of Human Genetics, Vol. 68, No. 3, July 2001, pp. 82-91.
• Rocca WA, Bower JH, McDonnell SK, Peterson BJ, Maraganore DM:  Time Trends in the Incidence of Parkinsonism in Olmsted County, Minnesota:  Neurology, Vol. 57, No. 3, August 2001, pp. 462-467.
• Benedetti MD, Maraganore DM, Bower JH, McDonnell SK, Peterson BJ, Ahlskog JE, Schaid DJ, Rocca WA:  Hysterectomy, Menopause and Estrogen Use Preceding Parkinson’s Disease: An Exploratory Case-Control Study:  Movement Disorders, Vol. 16, No. 5, September 2001, pp. 830-837.
• Wang L, McDonnell SK, Elkins DA, Slager SL, Christensen E, Marks AF, Cunningham JM, Peterson BJ, Jacobsen SJ, Cerhan JR, Blute ML, Schaid DJ, Thibodeau SN:  Role of HPC2/ELAC2 in Hereditary Prostate Cancer:  Cancer Research, Vol. 61, No.17, September 2001, pp. 6494-6499.
• Schaid DJ, McDonnell SK, Cunningham JM, Peterson BJ, Thibodeau SN:  General Tests for Departures from Hardy-Weinberg Proportions with Pedigree Data:  The American Journal of Human Genetics, Vol. 69, No. 4 suppl., October 2001, pp. 397.
• Elbaz A, Bower JH, Maraganore DM, McDonnell SK, Peterson BJ, Ahlskog JE, Schaid DJ, Rocca WA:  Risk Tables for Parkinsonism and Parkinson’s Disease:  Journal of Clinical Epidemiology, Vol. 55, No. 1, January 2002, pp. 25-31.
• Elbaz A, Peterson BJ, Yang P, Van Gerpen JA, Bower JH, Maraganore DM, McDonnell SK, Ahlskog JE, Rocca WA:  Nonfatal Cancer Preceding Parkinson’s Disease: A Case-Control Study:  Epidemiology, Vol. 13, No. 2, March 2002, pp. 157-164.
• Wang L, McDonnell SK, Elkins DA, Slager SL, Christensen E, Marks AF, Cunningham JM, Peterson BJ, Jacobsen SJ, Cerhan JR, Blute ML, Schaid DJ, Thibodeau SN:  Analysis of the RNASEL Gene in Familial and Sporadic Prostate Cancer:  The American Journal of Human Genetics, Vol. 71, No. 1, July 2002, pp. 116-123.
• Jacobsen SJ, Thibodeau SN, McDonnell SK, Peterson BJ, Bergstralh EJ, Schaid DJ, Blute ML:  Lack of Referral Bias in Genetic Studies of Prostate Cancer:  Epidemiology, Vol. 13, No. 5, September 2002, pp. 612-613.
• Elbaz A, Bower JH, Peterson BJ, Maraganore DM, McDonnell SK, Ahlskog JE, Schaid DJ, Rocca WA:  Survival Study of Parkinson Disease in Olmsted County, Minnesota:  Archives of Neurology, Vol. 60, No. 1, January 2003, pp. 91-96.
• Dong X, Wang L, Taniguchi K, Wang X, Cunningham JM, McDonnell SK, Qian C, Marks AF, Slager SL, Peterson BJ, Smith DI, Cheville JC, Blute ML, Jacobsen SJ, Schaid DJ, Tindall DJ, Thibodeau SN, Liu W:  Mutations in CHEK2 Associated with Prostate Cancer Risk:  The American Journal of Human Genetics, Vol. 72, No. 2, February 2003, pp. 270-280.
• Slager SL, Schaid DJ, Cunningham JM, McDonnell SK, Marks AF, Peterson BJ, Hebbring SJ, Anderson S, French AJ, Thibodeau SN:  Confirmation of Linkage of Prostate Cancer Aggressiveness with Chromosome 19q:  The American Journal of Human Genetics, Vol. 72, No. 3, March 2003, pp. 759-762.
• Bower JH, Maraganore DM, Peterson BJ, McDonnell SK, Ahlskog JE, Rocca WA:  Head Trauma Preceding PD:  A Case-Control Study:  Neurology, Vol. 60, No. 10, May 2003, pp. 1610-1615.
• Cunningham JM, McDonnell SK, Marks A, Hebbring S, Anderson SA, Peterson BJ, Slager S, French A, Blute ML, Schaid DJ, Thibodeau SN:  Genome Linkage Screen for Prostate Cancer Susceptibility Loci:  Results From the Mayo Clinic Familial Prostate Cancer Study:  Prostate, Vol. 57, No. 4, December 2003, pp. 335-346.
• Rocca WA, Peterson BJ, McDonnell SK, Bower JH, Ahlskog JE, Schaid DJ, Maraganore DM:  The Mayo Clinic Family Study of Parkinson’s Disease:  Study Design, Instruments, and Sample Characteristics:  Neuroepidemiology, Vol. 24, No. 3, February 2005, pp. 151-167.
• Elbaz A, Peterson BJ, Bower JH, Yang P, Maraganore DM, McDonnell SK, Ahlskog JE, Rocca WA:  Risk of Cancer After the Diagnosis of Parkinson’s Disease: A Historical Cohort Study:  Movement Disorders, Vol. 20, No. 6, June 2005, pp. 719-725.
• Michael KA, Peterson BJ, Yue AM, Wilson RD, Wang L, Ousdigian K, Wilkoff B, Sterns L, Morgan JM, for the Worldwide EMPIRIC Investigators: Use of an Intracardiac Electrogram Eliminates the Need for a Surface ECG during Implantable Cardioverter-Defibrillator Follow-up: Pacing and Clinical Electrophysiology, Vol. 30, December 2007, pp. 1432-1437.
• Chow T, Kereiakes DJ, Onufer J, Woelfel A, Gursoy S, Peterson BJ, Brown ML, Pu W, Benditt DG, on behalf of the MASTER Trial Investigators: Does Microvolt T-Wave Alternans Testing Predict Ventricular Tachyarrhythmias In Patients with Ischemic Cardiomyopathy and Prophylactic Defibrillators?: The MASTER Trial: J Am Coll Cardiol, Vol. 52, 2008, pp. 1607-1615.
• Chung ES, Katra RP, Ghio S, Bax J, Gerritse B, Hilpisch K, Peterson BJ, Feldman DS, Abraham WT: Cardiac Resynchronization therapy may benefit patients with left ventricular ejection fraction >35%: a PROSPECT Trial Substudy: European Journal of Heart Failure, Vol. 12, 2010, pp. 581-587.
• Van Gelder IC, Phan HM, Wilkoff BL, Brown ML, Rogers T, Peterson BJ, Birgersdotter-Green UM: Prognostic Significance of Atrial Arrhythmias in a Primary Prevention ICD Population: Pacing and Clinical Electrophysiology, Vol. 34, 2011, pp. 1070-1079.
• Hsing JM, Selzman KA, Leclercq C, Pires LA, McLaughlin MG, McRae SE, Peterson BJ, Zimetbaum PJ: Paced Left Ventricular QRS Width and ECG Parameters Predict Outcomes After Cardiac Resynchronization Therapy: PROSPECT-ECG Substudy: Circ Arrhythm Electrophysiol, Vol. 4, 2011, pp. 851-857.
• Sullivan RM, Murillo J, Gerritse B, Chung E, Orlov MV, Stegemann B, Fedewa M, Peterson BJ, Sun JP, Olshansky B: Do Baseline Diastolic Echocardiographic Parameters Predict Outcome after Resynchronization Therapy? Results from the PROSPECT Trial: Pacing and Clinical Electrophysiology, Vol. 00, 2012, pp. 1-7. doi: 10.1111/pace.12042.
• Gonzalez-Zuelgaray J, Pellizon O, Muratore CA, Oropeza ES, Rabinovich R, Ramos JL, Tentori MC, Reyes N, Aguayo R, Marin J, Peterson BJ: Lack of Current Implantable Cardioverter Defibrillator Guidelines Application for Primary Prevention of Sudden Cardiac Death in Latin American Patients with Heart Failure: A Cross-Sectional Study: Europace, Vol. 15, 2013, pp. 236-242.
• Silver MT, Sterns LD, Piccini JP, Joung B, Ching C, Pickett RA, Rabinovich R, Liu S, Peterson BJ, Lexcen DR: Feedback to Providers Improves Evidence-Based Implantable Cardioverter-Defibrillator Programming and Reduces Shocks: Heart Rhythm, Vol. 12, Issue 3, 2015, pp. 545-553, ISSN 1547-5271, http://dx.doi.org/10.1016/j.hrthm.2014.11.002.
• Rickard J, Whellen D, Sherfesee L, Peterson BJ, Nahey T, Tang AS, Ellenbogen KA, Cheng A: Characterization of Health Care Utilization in Patients Receiving Implantable Cardioverter-Defibrillator Therapies: An Analysis of the Managed Ventricular Pacing Trial: Heart Rhythm, Vol. 14, 2017, pp. 1382-1387.
• Wells P, Dubuc M, Klein GJ, Dan D, Roux J-F, Lockwood E, Sturmer M, Dunbar D, Novak P, Rao A, Peterson BJ, Kueffer F, Ellenbogen KA and for the ICY-AVNRT Investigators. Intracardiac ablation for atrioventricular nodal reentry tachycardia using a 6 mm distal electrode cryoablation catheter: Prospective, multicenter, north american study (ICY-AVNRT STUDY): J Cardiovasc Electrophysiol, 2017, https://doi.org/10.1111/jce.13367.
• Peterson BJ, Rocca WA, Bower JH, Savica R, Mielke MM: Identifying Incident Parkinson’s Disease Using Administrative Diagnostic Codes: A Validation Study: Clinical Parkinsonism & Related Disorders, Vol. 3, 2020, Page 100061, ISSN: 2590-1125, http://doi.org/10.1016/j.prdoa.2020.100061.