Amir Bahari

amir.bahari@email.com | +98 21 8847 5392 | Azadi Avenue, Tehran, Iran | linkedin.com/in/amirbahari

PROFESSIONAL SUMMARY

Accomplished biostatistics leader with 15+ years of experience driving statistical strategy and execution across clinical development programs in oncology, neuroscience, and cardiovascular therapeutic areas. Proven track record of leading cross-functional teams, advancing drug development from early-phase through regulatory submissions, and building high-performing biostatistics organizations. Expert in adaptive trial designs, biomarker integration, and translational science applications.

PROFESSIONAL EXPERIENCE

Senior Director, Biostatistics
Novus Pharma Solutions | Boston, MA | January 2020 – Present

• Lead biostatistics strategy and operations for a portfolio of 12+ clinical programs spanning oncology, Alzheimer's disease, and cardiovascular indications with combined budget exceeding $300M annually
• Direct team of 18 biostatisticians and programmers supporting Phase I-III trials, providing mentorship and technical oversight on complex statistical methodologies
• Collaborate with Clinical Development, Regulatory Affairs, and Data Sciences to design innovative adaptive trials incorporating predictive biomarkers, reducing development timelines by 18 months
• Serve as statistical lead for two successful IND submissions and one NDA filing in rare oncology indications
• Establish statistical standards and SOPs aligned with ICH guidelines, improving audit readiness scores by 35%

Director, Biostatistics
Catalyst Clinical Research | San Francisco, CA | June 2016 – December 2019

• Managed biostatistics support for oncology and pediatric clinical programs across 8 global trials with 2,500+ patients enrolled
• Designed statistical analysis plans for pivotal Phase III trials in solid tumors, incorporating novel endpoints and biomarker-driven subgroup analyses
• Led statistical contributions to regulatory interactions with FDA and EMA, resulting in accelerated approval pathway designation for two assets
• Built and mentored team of 9 biostatisticians, implementing competency development framework that reduced turnover by 40%
• Partnered with translational science teams to integrate genomic and proteomic biomarkers into clinical trial designs

Senior Principal Statistician
Precision Therapeutics Inc. | Princeton, NJ | March 2013 – May 2016

• Served as lead statistician for 5 Phase II/III oncology trials, overseeing protocol development, randomization, interim analyses, and final reporting
• Developed Bayesian adaptive designs for early-phase oncology studies, optimizing dose-finding and patient allocation strategies
• Contributed statistical expertise to cross-functional leadership teams for two major drug development programs in immuno-oncology
• Authored statistical sections of regulatory submissions, clinical study reports, and peer-reviewed publications (15+ manuscripts)
• Provided statistical consultation on biomarker validation studies and companion diagnostic development

Principal Statistician
Vertex Biomedical Consulting | Philadelphia, PA | August 2009 – February 2013

• Designed and analyzed Phase I-II clinical trials in cardiovascular disease and metabolic disorders
• Implemented innovative statistical methods for longitudinal data analysis and missing data handling in clinical trials
• Collaborated with Data Management and Clinical Operations to ensure data quality and protocol compliance
• Supported regulatory submissions including responses to FDA information requests and advisory committee briefing materials

Statistician
Meridian Clinical Solutions | New York, NY | July 2007 – July 2009

• Conducted statistical analyses for early-phase clinical trials in oncology and neurology
• Developed SAS programs for efficacy and safety analyses, tables, listings, and figures
• Participated in protocol development and statistical analysis plan writing for multiple studies

EDUCATION

Ph.D., Biostatistics
University of Tehran Institute of Advanced Studies | Tehran, Iran | 2007
Dissertation: Adaptive Methods for Clinical Trials with Time-to-Event Endpoints

M.S., Statistics
Sharif University of Technology | Tehran, Iran | 2003

B.S., Mathematics with Biology Minor
University of Isfahan | Isfahan, Iran | 2001

TECHNICAL SKILLS

Statistical Methods: Clinical trial design, adaptive designs, survival analysis, longitudinal data analysis, Bayesian methods, missing data imputation, multiplicity adjustment, biomarker analysis

Software: SAS, R, NONMEM, WinBUGS, EAST, nQuery

Therapeutic Areas: Oncology, Alzheimer's disease, cardiovascular disease, pediatrics, rare diseases

Regulatory: ICH guidelines (E3, E9, E9-R1), FDA/EMA interactions, IND/NDA submissions

SELECTED PUBLICATIONS

• Bahari, Amir, et al. "Biomarker-driven adaptive trial designs in precision oncology." Clinical Trials Journal, 2022.
• Bahari, Amir, et al. "Statistical considerations for Alzheimer's disease trials with cognitive endpoints." Neurology Research, 2021.
• Bahari, Amir, et al. "Bayesian methods for early-phase dose-finding in oncology." Statistics in Medicine, 2019.

PROFESSIONAL AFFILIATIONS

• American Statistical Association (ASA) – Member
• Society for Clinical Trials (SCT) – Member
• Biopharmaceutical Section of ASA – Member
• Statistical Programmers and Analysts Special Interest Group (SPASIG) – Member

LEADERSHIP & MENTORING

• Mentor for 6 junior biostatisticians through company mentorship program
• Speaker at industry conferences on adaptive trial designs and biomarker integration
• Member of company-wide Statistics Leadership Council