Summary
Overview
Work History
Education
Skills
Reviewer Service
Publications
Presentations
Research
Timeline
Generic

SHANJUN HELIAN

Pittsfield

Summary

Accomplished biostatistician specializing in all phases of clinical trials in oncology, stroke, and vaccine areas. Driving decision maskings through strategic statistical analysis and risk assessment. Experienced at cross-functional communications and managing delivery timeline.

Overview

14
14
years of professional experience

Work History

Associate Director

BioNTech
Cambridge
12.2023 - Current
  • Project lead statistician of B7H3 ADC
  • Conducted statistical analysis to support Japan enrollment strategies in Phase 3 study, resulting in PMDA approval.
  • Led cross-functional teams discussion to assess the risk of enrolling certain types of participants to determine the study stratification factors
  • Interpreted FDA's recommendation on conducting open-label Phase 3 study and authored masking plan and working process for open-label Phase 3 studies.
  • Led and Coordinated resources among internal stat team, external vendor/contractors, and partner companies, to ensure high-quality TFLs delivery on time, including publications, IRC/SRC/IDMC meetings, and internal study milestone decision making.
  • Authored multiple Phase 1/2 and Phase 3 Statistical Analysis Plans (SAP) in solid tumor disease indications, including NSCLC, SCLC, CRPC, etc.
  • Presented Phase 3 study designs and options to CEO and senior management, securing endorsement for project direction.
  • Analyzed and compared cross-trial data and publication/competitor data for senior management review on decision making.
  • Contributed to the protocol objectives/endpoints discussion, randomization/blinding strategy assessment, and authored the statistical analysis section
  • Evaluated the impact of different tumor assessment schedules to guide protocol rationale.
  • Provided the strategy of health outcome endpoints analysis as the Phase 3 study secondary endpoints.

Senior Principal Biostatistician

Biogen
Cambridge
06.2021 - 12.2023
  • Project lead statistician of ischemic stroke program.
  • Developed Clinical Development Plan (CDP) of Phase 2b & Phase 3 studies and presented the statistical considerations in the internal governance meetings and external advisory board meetings.
  • Authored briefing documents for statistics-related topics for pre-IND interaction with different regulatory agencies (FDA, EU national regulatory agencies, and PMDA) and addressed feedback.
  • Authored protocol and SAP for a 2-part, operationally seamless, Ph2b study design by using early outcome (binary) in Part 1 for dose selection and long-term clinical outcome (ordinal) in Part 2, and compared with 2-part inferential seamless design
  • Developed dose selection decision framework, presented at the project core team meeting and got project team endorsement.
  • Developed Bayesian Go/No-Go decision framework for Part 2 based on simulated Part 1.
  • Led the cross-functional teams discussion of identifying the intercurrent events (ICEs) and strategies for addressing the ICEs for the primary and secondary endpoints.
  • Led discussions with IRT vendor to develop a covariates adaptive randomization algorithm that maintained balance on key prognostic factors.
  • Led cross functional team’s discussion on potential head-to-head Ph3 study design by considering possible positive outcomes from competitor and completed a memo for executive committee within 1 week.
  • Led cross functional team’s discussion on potential head-to-head Ph3 study design by considering possible positive outcomes from competitor and completed a memo for executive committee within 1 week.
  • Received multiple recognition awards for outstanding contributions to projects.
  • Accountable: for going above and beyond for the work on stats/sample sizes calculation/discussion in the program and the framework built
  • Accountable: for validating Ph3 Go/No-Go decision based on Ph2 results for a Neurovascular program
  • Agile: for successful first interaction with FDA, which helped improvement of CDP
  • Agile: for supporting interim analysis of a Phase 3 study as unblinded statistician
  • Inclusive: for sharing knowledge on Ph2b study design with China team
  • Pioneering: for presenting at Biostatistics Seminar, sharing knowledge and experience with other biostatisticians regarding sample size calculation framework, Go/No-Go considerations, and communication with other function groups
  • Pioneering: for strategic foresight and pioneering mindset to improve the feasibility of Phase 2b study by making a quick turnaround through protocol amendment

Associate Principal Scientist

Merck & Co.
Upper Gwynedd
01.2020 - 06.2021
  • Lead statistician of multiple vaccine Phase 3 studies
  • Designed event-driven vaccine efficacy study with 2 interim analyses, developing SAS programs for analysis based on established trial design
  • Provided statistical input in the discussions regarding power and sample size calculation and timeline projection
  • Authored the statistical Analysis Plan (SAP) in the protocols and supplemental Statistical Analysis Plans (sSAP)
  • Designed mock-up TLFs package for CSR and external Data Monitoring Committee (eDMC)
  • Led the A&R activities for the CSRs authoring
  • Program lead statistician of multiple vaccine programs
  • Participated in team discussions for type C meeting backgrounder preparation as statistician representative for multiple studies
  • Reviewed multiple CSRs, providing statistical inputs that supported successful submissions to regulatory agencies
  • Joined BARDS Stratified Medicine Contest 2020. Explored different methods in identifying potential stratification factors or subpopulation for late phase study designs based on the early phase trial data. Won best presentation award
  • Joined the COVID PD vaccine working group as the statistician representative and contributed to the release of guidance about how to handle COVID PDs with additional information in the CSR
  • Received multiple awards of excellence for outstanding working performance
  • Best presentation award in BARDS Stratified Medicine Contest 2020

Senior Scientist

Merck & Co.
Upper Gwynedd
06.2016 - 01.2020
  • Lead statistician of multiple Phase 3 studies
  • Authored Statistical Analysis Plans (SAP), presented to interval review committees, addressed senior management and regulatory agency comments, securing approval across multiple regions
  • Provided statistical input in the discussions regarding different hypothesis testings, power and sample size calculation, and contributed to the text in the primary/secondary objectives of the protocol
  • Designed assay testing priority plan to guide the lab in determining the order of sample testing based on the dosing schedule and serum volume
  • Lead statistician of integrated Summary Reports for multiple vaccine programs
  • Authored the integrated Statistical Analysis Plans (iSAP) of the integrated Summary of Immunogenicity (ISI) and safety (ISS)
  • Created table shells and facilitated TLFs discussion meetings across functional areas, ensuring clarity and accuracy for successful regulatory submissions
  • Provided statistical support for non-human primate (NHP) data, developed analysis programs using logistic regression and random forest methods to explore correlates of protection, contributing to successful study report submissions to regulatory agencies
  • Served as unblinded statistician for one Phase 1 vaccine study
  • Led interim analyses and safety review activities, including resolve data issues and review outputs
  • Provided TLFs to standing internal Data Monitor Committee (siDMC) and supported ad hoc requests
  • Explore the design/testing methods of Multi-Regional Clinical Trial (MRCT), including literature review, give presentations in company group meetings, join the study group discussion, and contributed to the release of the internal guidance
  • Co-developed multiple Vaccine TA standard SAS macros
  • Received multiple awards of excellence for outstanding working performance

Statistician (Research Assistant)

Children Oncology Group
Gainesville
09.2012 - 05.2016
  • Provided statistical support for Acute Lymphoblastic Leukemia (ALL) clinical trials and contributed to two publications
  • Performed statistical analysis using SAS and R for multiple clinical trials, including survival analysis and logistic regression
  • Collaborated with other statisticians, programmers and clinical research scientists as appropriate

Education

Ph.D. - Biostatistics

University of Florida
Gainesville, FL
05-2016

M.S. - Civil Engineering

University of Central Florida
Orlando, FL
08-2011

B.S. - Civil Engineering

Southwest Jiaotong University
Chengdu, China
06-2009

Skills

  • SAS/SQL
  • SAS/BASE
  • SAS/STAT
  • SAS/MACRO
  • SAS/IML
  • SAS/ODS
  • SAS/GRAPH
  • R, gsdesign, simtrial
  • NQuery
  • Microsoft Office
  • LaTeX

Reviewer Service

Journal of Biopharmaceutical Statistics, 4

Publications

  • A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (MMR II)., Silas, P. E., Zissman, E. N., Gardner, J., Helian, S., Lee, A. W., Platt, H. L., Human vaccines & immunotherapeutics, 16, 11, 2634-2640, 2020
  • Sparse canonical correlation analysis between an alcohol biomarker and self-reported alcohol consumption., Helian, S., Brumback, B. A., Cook, R. L., Communications in Statistics-Simulation and Computation, 7924-7941, 2017
  • Neurocognitive Functioning of Children Treated for High-Risk B-Acute Lymphoblastic Leukemia Randomly Assigned to Different Methotrexate and Corticosteroid Treatment Strategies: A Report from the Children’s Oncology Group., Hardy, K. K., Embry, L., Kairalla, J. A., Helian, S., Devidas, M., Armstrong, D., ..., Loh, M. L., Journal of Clinical Oncology, 35, 23, 2700-2707, 2017
  • Reply to IJ Cohen., Hardy, K. K., Embry, L., Kairalla, J. A., Helian, S., Devidas, M., Armstrong, D., ..., Loh, M. L., Journal of Clinical Oncology, 35, 35, 3989-3991, 2017
  • Structural Nested Models for Cluster-Randomized Trials., Helian, S., Brumback, B. A., Freeman, M. C., Rheingans, R., Statistical Causal Inferences and Their Applications in Public Health Research, 169-186, Springer International Publishing Switzerland, 2016
  • Outcomes of dasatinib plus intensive chemotherapy or stem cell transplant (SCT) for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) on Children’s Oncology Group AALL0622., Slayton, W. B., Kairalla, J. A., Schultz, K. R., Devidas, M., Helian, S., Pulsipher, M., ..., Winick, N. J., Journal of Clinical Oncology, 33, 15_suppl, 10006-10006, 2015

Presentations

  • Sparse Canonical Correlation Analysis Between an Alcohol Biomarker and Self-Reported Alcohol Consumption., 02/16, Florida ASA Chapter Meeting, Tallahassee, FL
  • Structural Nested models for Cluster-Randomized Trials., 09/15, Research Day of Public Health and Health Professions, Gainesville, FL
  • Analysis of Stratified Clinical Trials with Time-To-Event Endpoints, 08/18, JSM, Vancouver, Canada

Research

  • Penalized Correlation and Partial Correlation Analysis, Gainesville, FL, 09/14, 05/16, Developed a new approach of sparse Canonical Correlation Analysis by incorporating Lasso penalty in the linear model with step functions and proved this approach solves an optimization problem., Applied the new sparse Canonical Correlation Analysis method in the WHAT-IF trial to estimate the correlation between the Phosphatidylethanol (PEth) test values and daily self-reported alcohol consumption., Implemented the sparse Canonical Correlation Analysis method using R with weighted cross-validation error and individual sampling weights, and performed simulation studies to verify the method.
  • Structural Nested Models for Cluster-Randomized Trials, Gainesville, FL, 10/13, 08/14, Developed structural nested models with different link functions (linear, log linear and logistic) to estimate the causal effect of adherence level to the treatment in a three-armed cluster randomized trial using SAS., Applied structural nested models with different link functions in the school-based WASH study to estimate the cluster-level adherence on an individual-level outcome., Explored three different methodologies to construct confidence intervals: sandwich estimator, bootstrap, and jackknife.

Timeline

Associate Director

BioNTech
12.2023 - Current

Senior Principal Biostatistician

Biogen
06.2021 - 12.2023

Associate Principal Scientist

Merck & Co.
01.2020 - 06.2021

Senior Scientist

Merck & Co.
06.2016 - 01.2020

Statistician (Research Assistant)

Children Oncology Group
09.2012 - 05.2016

Ph.D. - Biostatistics

University of Florida

M.S. - Civil Engineering

University of Central Florida

B.S. - Civil Engineering

Southwest Jiaotong University
SHANJUN HELIAN