Erik Bergström

erik.bergstrom@protonmail.se | +46 8 742 5893 | Västra Vägen 47, 171 54 Solna | https://www.linkedin.com/in/erikbergstrom

PROFESSIONAL SUMMARY

Accomplished Principal Statistician with 15+ years of experience in clinical trial design, statistical analysis, and regulatory submissions across multiple therapeutic areas including oncology, immunology, hematology, and neurology. Proven expertise in leading biostatistical strategies for late-phase clinical development programs, with deep knowledge of adaptive trial designs, predictive modeling, and innovative statistical methodologies. Recognized for delivering high-quality statistical analysis plans, regulatory documents, and peer-reviewed publications while mentoring cross-functional teams and junior statisticians.

PROFESSIONAL EXPERIENCE

Principal Statistician
Scandinavian Pharma Solutions, Stockholm
January 2019 - Present

Lead biostatistical support for global Phase II-IV clinical trials in oncology and immunology therapeutic areas, providing strategic input on study design, sample size determination, interim analyses, and final statistical reporting. Collaborate with clinical operations, medical affairs, regulatory, and data management teams to ensure statistical rigor and regulatory compliance across all clinical development activities.

- Serve as lead statistician for 8+ pivotal oncology trials, including novel mRNA-based therapeutic programs, resulting in 3 successful regulatory submissions
- Design and implement complex adaptive trial designs and Bayesian methodologies, reducing patient recruitment timelines by 25% while maintaining statistical power
- Author statistical analysis plans, protocols, clinical study reports, and contribute to regulatory submissions (IND, NDA, BLA) for FDA and EMA
- Develop and validate SAS macros and R packages for simulation studies, interim monitoring, and predictive modeling of clinical endpoints
- Mentor team of 5 statisticians and provide statistical consulting to cross-functional project teams across multiple therapeutic areas
- Lead statistical review and interpretation of safety and efficacy data for Data Safety Monitoring Boards and independent review committees
- Contribute to 12+ peer-reviewed manuscripts and present findings at major oncology and hematology conferences

Senior Statistician
Nordic Clinical Research, Gothenburg
March 2014 - December 2018

Provided comprehensive statistical support for Phase I-III clinical trials in hematology, oncology, and neurology, with focus on complex endpoint analysis, longitudinal data modeling, and survival analysis. Collaborated with bioinformatics teams to integrate genomic and biomarker data into clinical trial analyses.

- Led statistical design and analysis for 15+ clinical studies across various cancer indications, including rare hematologic malignancies
- Developed innovative statistical methodologies for patient-reported outcomes and quality of life assessments in oncology trials
- Created automated reporting tools using SAS, R, and Python to streamline data analysis workflows and reduce analysis time by 40%
- Conducted Monte Carlo simulations to evaluate operating characteristics of proposed trial designs and optimize study parameters
- Collaborated with biometrics and bioinformatics teams to develop predictive models incorporating genomic biomarkers
- Contributed statistical expertise to protocol development, data monitoring committee reports, and regulatory interactions
- Published 8 manuscripts in high-impact journals and co-authored multiple abstracts for international conferences

Statistician
Biostat Consulting Group, Uppsala
June 2010 - February 2014

Performed statistical programming, analysis, and reporting for clinical trials in immunology and neurology therapeutic areas. Supported protocol development, sample size calculations, and statistical analysis plan preparation for early to mid-phase clinical studies.

- Conducted statistical analyses using SAS and R for 20+ Phase I-II clinical trials in autoimmune diseases and neurological disorders
- Developed and validated SAS programs for CDISC-compliant datasets (SDTM, ADaM) and TLFs for regulatory submissions
- Performed interim analyses and provided statistical support for dose-finding studies and proof-of-concept trials
- Collaborated with clinical teams on protocol amendments, statistical sections, and study design optimization
- Created comprehensive documentation for statistical methods and programming code following SOPs and regulatory guidelines
- Participated in cross-functional project teams and contributed to investigator meetings and study start-up activities

Junior Statistician
Karolinska Research Institute, Stockholm
August 2008 - May 2010

Provided statistical programming and analytical support for clinical research studies. Assisted senior statisticians with data analysis, report generation, and quality control activities for clinical trial deliverables.

- Performed statistical analyses and generated tables, listings, and figures for clinical study reports using SAS
- Conducted data quality checks and validation of clinical databases prior to database lock
- Assisted with sample size calculations, randomization procedures, and statistical analysis plan development
- Developed SAS macros for routine analysis tasks and contributed to department programming standards
- Supported literature reviews and meta-analyses for evidence-based decision making in clinical development

EDUCATION

Doctor of Philosophy (Ph.D.) in Biostatistics
Uppsala University, Uppsala
Graduated: May 2008
Dissertation: "Adaptive Bayesian Methods for Survival Analysis in Oncology Clinical Trials"

Master of Science (M.S.) in Statistics
Lund University, Lund
Graduated: May 2004

Bachelor of Science (B.S.) in Mathematics
Royal Institute of Technology, Stockholm
Graduated: May 2002
Minor: Computer Science

TECHNICAL SKILLS

Statistical Software: SAS (Base, STAT, GRAPH, Macro), R, Python, STATA, S-PLUS
Programming Languages: SQL, Perl, Python, Unix/Linux shell scripting
Statistical Methods: Clinical trial design, survival analysis, longitudinal data analysis, Bayesian methods, adaptive designs, mixed models, predictive modeling, simulation studies, meta-analysis, interim monitoring
Regulatory Standards: ICH guidelines, FDA/EMA regulations, CDISC (SDTM, ADaM), GCP
Therapeutic Expertise: Oncology, hematology, immunology, neurology, rare diseases
Additional: Protocol development, SAP writing, CSR preparation, regulatory submissions, manuscript preparation, statistical consulting

PUBLICATIONS & PRESENTATIONS

Author/co-author of 25+ peer-reviewed publications in journals including Journal of Clinical Oncology, Lancet Oncology, Blood, and Statistics in Medicine
Presenter at ASA, ENAR, PSI, ASH, ASCO, and other professional conferences
Regular contributor to regulatory guidance documents and industry white papers on statistical methodology

PROFESSIONAL AFFILIATIONS

American Statistical Association (ASA), Member
International Biometric Society (IBS), Member
Statisticians in the Pharmaceutical Industry (PSI), Member
Society for Clinical Trials (SCT), Member

CERTIFICATIONS

SAS Certified Advanced Programmer
Statistical Programming Associate Certification