Summary
Overview
Work History
Education
Skills
Accomplishments
Publications
Certification
Software Skills
Timeline
Generic

Varuna Astha

New York,NY

Summary

Highly accomplished and driven senior-level Biostatistician with a broad knowledge of statistical techniques for various types of clinical trials and real world evidence(RWE) study design and research projects. With an in-depth knowledge of SAS & R programming, including CDISC, SDTM and AdaM, I excel at designing and overseeing clinical trial production of data sets and tables, figures and listings(TFLs).I am a skilled verbal communicator and can explain complex statistical concepts to non-statisticians.

Overview

22
22
years of professional experience
1
1
Certification

Work History

Senior Biostatistician

Cytel Inc.
11.2022 - Current
  • · Offered comprehensive statistical support to pharmaceutical clients for their clinical trials and research studies, ensuring the accuracy and reliability of data analysis.
  • · Collaborated with a leading gene editing company dedicated to developing CRISPR medicines for individuals with serious rare diseases. Specifically, contributed to the following clinical trials:
  • Phase 1/2/3 Clinical Trial for Severe Sickle Cell Disease
  • Phase 1/2 Clinical Trial for Severe Beta Thalassemia
  • · Perform or oversee power/sample size calculations using SAS, nQuery, PASS etc. to determine appropriate trial size.
  • · Provide statistically sound experimental design and data analysis inputs to meet project objectives and regulatory requirements.
  • · Reviewed statistical sections for clinical trial protocols and protocol amendments, ensuring alignment with regulatory guidelines and industry best practices.
  • · · Developed Statistical Analysis Plans (SAPs) with strategic visit windows tailored for complex clinical trials, demonstrating proficiency in protocol design and execution.
  • · Design and conduct statistical analysis of clinical data or oversee this work.
  • · Developed Table Figure and Listing (TFL) mock shells and meticulously reviewed Table, Figure and Listing (TFL) outputs for consistency and accuracy.
  • · · Provided oversight of SDTM/ADaM specifications and analysis datasets, ensuring the highest standards of data integrity and compliance with regulatory requirements. Performed and documented QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints.
  • · Write statistical sections of regulatory submissions or oversee this work.
  • · Led Interim Analysis initiatives, crafting comprehensive IA plan, mock shells and overseeing TFL outputs, demonstrating proficiency in FDA submission requirements and contributing to strategic decision-making processes.
  • · Provided essential support for Regenerative Medicine Advanced Therapy (RMAT) Designation, showcasing expertise in regulatory processes, and contributing to successful FDA submissions.
  • · Conducted advanced health-related quality of life (HRQOL) analyses, employing cutting-edge measures such as PROMIS-57, ASCQ-Me, and EQ-5D-5L to provide nuanced insights into patient-reported outcomes.
  • · Collaborated with the study programming team for study deliverables. Facilitated effective collaboration between programming, clinical, and regulatory teams, ensuring seamless integration of feedback and alignment with study protocol.
  • · Contributed to Abstracts for high-profile conferences (including ASH) and prepared, showcasing key statistical insights and supporting strategic decision-making processes.
  • · Drafted and reviewed statistical sections of regulatory submissions including Briefing Book documentation, RMAT submission and Interim Analysis report submission, demonstrating a keen understanding of regulatory requirements, and contributing to successful approvals.

Vice President of Fixed Income Strategy

RBS Greenwich Capital
06.2005 - 03.2008
  • Developed forecasts using S-plus and SAS and performed statistical analysis on financial data and spot trends.
  • Wrote reports and presentations on recommendations to buy or sell investments and securities.
  • Developed statistical arbitrage trading strategies and back-test trading signals on prior time periods to evaluate the effectiveness of the strategies using SAS.
  • Advised institutional investors on relative value trading ideas for profit maximization and risk management for mortgage backed security portfolios.
  • Led the team that ranked third (3rd) in Institutional Investor magazine's mortgage backed security research survey.

Biostatistician

PPD Development
11.2002 - 06.2005
  • Acted as statistician on several clinical trials, including one Phase I crossover PK, one Phase II, multiple non-inferiority Phase III and two post-market Phase IV studies in following therapeutic areas: anti-infective (antibiotic), cardiovascular (cholesterol), respiratory (ARDS) and Gastroenterology (GERD).
  • Developed statistical analysis plans, table shells, analysis datasets and table programming specifications according ICH, FDA and CDISC guidelines.
  • Programmed and validated tables, listings, figures and analysis datasets and performed statistical analysis using SAS on both VMS and PC operation systems.
  • Performed survival, proc mixed, logistic and nonparametric analyses and CDISC dataset conversions.
  • Provided statistical expertise and participated in protocol design, sample size calculations, study randomization, case report form review, data review and report writing.

Senior Statistical Coordinator

University Of Pittsburgh School Of Medicine
01.2002 - 11.2002
  • Provided the statistical support to the department in terms of test and analysis using educational measurement approaches.
  • Imported Excel files into SAS for cleaning and analyses.
  • Provided SAS programming support for publication by performing analyses and generating statistical outputs.

Education

MPH - Biostatistics

University of South Florida (USF), Tampa, Florida,
Tampa, FL
2019

M.Tech - Health, Safety, & Environment

UPES University of Tomorrow
Dehradun, Uttarakhand
2013

B. Tech - Computer Science

Dr. A.P.J. Abdul Kalam Technical University (AKTU)
Lucknow, Uttar Pradesh, India
2011

Skills

  • Clinical trial study design and implementation
  • Sample size and power calculation
  • Randomization Lists
  • Table, Figure and Listing (TFL) mock shells
  • Statistical Analysis Plans
  • Statistical analysis of Phase I-III studies
  • SDTM, ADAM, CDISC datasets
  • Regulatory Submission Proficiency
  • Abstracts, posters, and medical manuscripts for Clinical trials and RWE studies

Accomplishments

    Successfully provided biostatistics support to clinical trials and real world evidence(RWE) research studies in a variety of therapeutic areas including genetic disorders/rare diseases, infectious diseases, allergy & immunology, gastroenterology, and oncology leading to IND and NDA submissions and/or poster, abstract, and manuscript publication in reputed medical journals.

Publications

Mendoza,T., Dueck, A., Shi, Q., Ma, H., Claire, J., Yi, Q., Cleeland, C. "The Significant Contribution of Pain in Determining the Health Status of Patients with Multiple Myeloma." American Society of Hematology (ASH) - 57th Annual Meeting, Orlando, FL; December 5-8, 2015

Ford-Johnson, L., DeLuca, J., Claire, J., Elovic, E., Lengenfelder, J., & Chiaravalloti, N.D. (in press). "Cognitive Effects of Modafinil in Patients with Multiple Sclerosis: A Clinical Trial." Rehabilitation Psychology.

Hreha, K., D'Souza, N., Keller, T., Claire, J. Y, Barrett, A. (2015) Inter-rater Reliability of the Kessler Foundation Neglect Assessment Process (KF-NAP): Effects of Training Students. 41st NJOTA Annual Conference, Hillside, New Jersey

Oyawusi, M., Levy, B., Gentile, A., March, G., Hreha, K., Pagaoa-Cruz, G., Masmela, J., Galletta, E., Holman, S., McKenna, C., Claire, J.Y., Barrett, A. (2015) Medication Self-Administration after Stroke - American Academy of Neurology 67th Annual Meeting (AAN), Washington, DC

Rudell, E., Peterson, P., Claire, J.Y., & DeLuca, J. (2012) Cognitive Dysfunction in MS: Education Translates Science into Practice. Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, San Diego, CA

Alverzo, J., Barrett A.M., Chen, P., Frisina, P.G., Hedeman, R., Kutlik, A., Lellella, M., McKenna, C., & Claire J.Y. (2011) Factors Correlated with Falls in Inpatient Stroke Patients. 6th Annual North East Cerebrovascular Consortium (NECC) Educational Summit, Boston, MA

McKenna, C., Alverzo, J., Chen, P., Claire, J.Y., Frisina, P.G., Kutlik, A., Oh-Park, M., Lellella, M., & Barrett, A.M. (2013) Prediction of Fall Risk Upon Admission to an Inpatient Stroke Unit, American Academy of Physical Medicine and Rehabilitation (AAPMR) Annual Assembly and Technical Exhibition, National Harbor, MD

Castilla-Puentes, R., Claire, J.Y., Bromberger, J., Perel, J.M., & Matthews, K. (2003) Depressed Women Have Elevated Coagulation Factors in Midlife. The American Psychiatric Association Preliminary Program Session: Women's Health

Acar EU, Choset H, Claire Y, Schervish M (2002). Path Planning for Robotic Demining: Robust Sensor-based Coverage of Unstructured Environments and Probabilistic Methods, accepted, International Journal of Robotics Research

Claire Y, Schervish M, Choset H (2002). Probabilistic Hierarchical Spatial Model for Mine Locations and its Application in Robotic Landmine Search. Proceedings of 2002 IEEE/RSJ International Conference on Intelligent Robots and Systems (IROS), 2002.

Claire Y, Schervish M, Acar EU, Choset H (2001). Probabilistic Methods for Robotic Landmine Search (II), Proceedings of 2001 IEEE/RSJ International Conference on Intelligent Robots and Systems (IROS), 2001.

Acar EU, Claire Y, Choset H, Schervish M (2001). Path Planning for Robotic Demining and Development of a Test Platform, Proceedings of the 3rd International Conference on Field and Service Robotics, 2001.

Choset H, Acar EU, Claire Y. Schervish M (2001). Sensor Based Coverage for Demining: Exact Cellular Decompositions and Uncertain Detectors, Proceedings of ASME International Mechanical Engineering Congress & Exposition, 2001.

Claire Y, Schervish M, Acar EU, Choset H (2000). Probabilistic Methods for Robotic Landmine Search (I), Proceedings of SPIE Vol. 4195: Mobile Robots XV and Telemanipulator and Telepresence Technologies VII. Technical Report

Claire Y. (2000), Hierarchical Modeling of Arsenic Concentrations at Entry Points in US Public Drinking Water Supplies, Technical Report 739, Department of Statistics, Carnegie Mellon University.

Certification

  • · Certified in Public Health (CPH) by the National Board of Public Health Examiners (NBPHE).
  • · Certified Peer Reviewer by Researcher Academy at ELSEVIER.
  • · Good Clinical Practice certification issued by CITI.
  • · HIPAA Privacy certification issued by CITI.
  • · Investigators/Research Staff certification issued by CITI.
  • · Biomedical Responsible Conduct of Research certification issued by CITI.
  • · Rave EDC Essentials for Clinical Research Coordinators issued by Medidata Academy.
  • · Advanced Rave EDC for Site Users issued by Medidata Academy.
  • · EDC Inspection Readiness for Clinical Sites issued by Medidata Academy

Software Skills

  • · SAS 9.4 (PC), SAS Life Science Analytics Framework (LSAF), R/ RStudio
  • · nQuery, PASS
  • · MS SQL, Tableau, REDCap
  • · Microsoft Office

Timeline

Senior Biostatistician

Cytel Inc.
11.2022 - Current

Vice President of Fixed Income Strategy

RBS Greenwich Capital
06.2005 - 03.2008

Biostatistician

PPD Development
11.2002 - 06.2005

Senior Statistical Coordinator

University Of Pittsburgh School Of Medicine
01.2002 - 11.2002

MPH - Biostatistics

University of South Florida (USF), Tampa, Florida,

M.Tech - Health, Safety, & Environment

UPES University of Tomorrow

B. Tech - Computer Science

Dr. A.P.J. Abdul Kalam Technical University (AKTU)
Varuna Astha