Adina I. Graf
Zofingen
Summary
A Doctorate in Biostatistics with strong medical background and more than 10 years experience in clinical research focusing on phase I-IV clinical trials and large epidemiological studies. I worked in multiple therapeutic areas such as immunology, neuroscience, cardiovascular, nutrition, radiation medicine, respiratory, oncology and pediatrics in drug development as well as in HTA and in digital health. Experience in leading projects and managing groups of people with clinical, programming, and operational backgrounds, in big pharma, small biotech companies as well as in academia. Involved in research activities resulting in authoring publications and presentations.
Demonstrated strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth.
Overview
33
33
years of professional experience
Work History
Director, Biostatistics
ADCT
10.2021 - Current
- Early development oncology programs lead involving phase 1 and phase 2 study design using advanced statistical methodology such as BOIN (Bayesian Optimal Interval) and mTPI (Modified Toxicity Probability Interval) design
- Lead statistician for the FDA submission of integrated summary of safety analysis (ISS) for one of the company compounds
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Facilitated cross-functional collaboration for improved decision-making processes within the organization.
Principal Scientist HTA
MSD
08.2020 - 10.2021
- Keytruda oncology project statistician focusing on operational aspects of HTA (Health Technology Assessment) submissions such as programming specifications, datasets and outputs validation
- In addition, statistical analysis plan and report writing, and review
- In collaboration with the methodology statistician, responsible for meta analysis in rare tumors framework using DerSimonian and Laird methodology
- Statistical strategic input
- Mentored junior scientists and provided guidance on experimental design, data interpretation, and professional development opportunities.
Senior Principal Biostatistician
Boehringer Ingelheim Pharmaceutical
06.2020 - 08.2020
- Involved in teaching biostatistics for non-statisticians as trainer and as coordinator
- Involved in recruiting summer interns in the biostatistics department
- Project statistician for immunology projects including phase 2 trials
- Working closely and offering guidance to trial statisticians to finalize statistical sections of the protocol, statistical analysis plans, and clinical trial reports
- Implemented data-driven decision-making processes to enhance overall business performance and profitability.
- Collaborated with stakeholders at various organizational levels to develop targeted strategies aligned with overarching business objectives.
Principal Biostatistician drug development and digital health
Boehringer Ingelheim Pharmaceutical
11.2014 - 06.2020
- Project statistician for complex projects focused on immunology, gastroenterology, cardiovascular, respiratory
- Involved in data interrogation and independent programming of primary and key secondary endpoints
- Involved in projects (hands on) using cutting edge statistical methodology such as MCP-Mod (Multiple Comparison Procedure-Modelling)
- Involved in FDA/EMA interactions for Risankizumab before it was taken over by Abbvie
- Responsible for respiratory clinical trial (phase IV) including a digital health component as a pilot sub-study
- This was a very complex task which involved collaborations across multiple functions such as information technology, clinical operations for remote trials in addition to regular functions involved usually in clinical trials
- Recipient of 2018 Presidential Award for running this first in the company digital health remote clinical trial
- Trainer and coordinator of the initiative of teaching statistics for non-statisticians
Director, Head of Biostatistics, Clinical Trials
Cogstate Ltd
01.2013 - 11.2014
- Hired and retained a group of four full time and two part time talented people: statistician, programmers, medical writers, and data monitors
- Leading a global statistical group with full time and part time employees in USA, Australia and external contractors in UK
- Reporting activities for sponsors; on average two high quality clinical study reports for cognition data results delivered each month
- Leading SOP writing and implementation
- Analysis of cognitive data (computerized tests and paper and pencil) using frequentist statistical methodology such as: ANCOVA and linear mixed model with repeated measures
- Bayesian methodology to calculate the posterior probabilities
Principal statistician
Pfizer Global R&D
11.2007 - 01.2013
- Project statistician for Phase I-III clinical trials in the therapeutic area of Neuroscience
- Protocol development responsibilities, including participation in discussions regarding strategies to move clinical programs forward
- Study design, study protocol review, writing and reviewing statistical sections of protocols and statistical analysis plans (SAPs)
- Project statistician for Phase I-III clinical trials in the therapeutic area of Cardiovascular Medicine
- Study design and analysis, using frequentist and Bayesian techniques
- Participation in go/no decisions
- Involvement in statistical specification of the study hypothesis, sample size estimation, power calculations, and statistical delineation of study endpoints
- Voting member on independent data review committees for interim analyses
- Co-author of the Interim Analysis Charter and Interim Analysis Statistical Plan
- Statistical programming in SAS, STATA, WINBUGS
- Carried out simulations in SAS, MATLAB and R
- FDA Interactions: Involvement in NDA (New Drug Application) submission preparation
- Contributor to briefing documents, written responses, and member of the Rapid Response Team responsible for addressing FDA queries
- One of the FDA submissions in which I was involved was approved
- Participation in FDA meetings and label negotiations
- Major contribution to the submission by performing a statistical analysis which established that the drop-outs can be considered to occur completely at random
- Supervision and Quality Control (using SAS) of statistical analysis results, including supervising SAS programmers and technical operation people
- Oversaw contract statisticians and programmers in creating analysis datasets file specification (CDISC compliant)
- Participation in the CRF design and implementation
- Continuous communication and negotiations with clinicians
- Presented statistical methodology to clinical personnel at investigator meetings and at meetings with key opinion leaders
- Authoring the Top Line Report and Clinical Study Report for Phase IIb and Phase III studies
- Reviewing the specification for laboratory and ECG data using medical expertise
Scientist/Statistician
ALZA Corporation (J&J)
01.2006 - 01.2007
- Lead Statistician of a Phase I and a Phase IIa in the therapeutic area of immunology
- Protocol development duties including study protocol review, writing of statistical section of the protocol, and writing the statistical analysis plan (SAP)
- Coordination of Data Monitoring Committee (DMC) Meetings for the Phase II study
- This task included defining which tables and listings to be delivered to DMC, blinded data review and answering questions asked by the study team and by the external DMC members
- Supervision and Quality Control (using SAS) of statistical analysis datasets and the interim study reports
- This responsibility involved supervising the SAS programmers and technical operation people and providing quick feedback regarding different issues
- Generating the Randomization Schedule for MAD (Multiple Ascending Dose) Phase I Study involving SAS macro and programming
- Creating analysis datasets file specification (CDISC compliant) and overseeing their implementation by the analyst team
- Working with Electronic Data Capture Systems RAVE-MEDIDATA and PDS (Phoenix Data System)
- Involved in the initial set-up, UAT (User Acceptance Testing) and implementation of the eCRF (Electronic Case Report Form)
- Providing necessary feedback and participation as a decision maker at each data migration
- Working with PDS involved fast communication across time zones within a multidisciplinary and multinational team (USA and Europe)
- Active involvement in the UAT for the IVRS (Interactive Voice Response System) used in the Phase II study; working with the IVRS databases
- Presenting statistical methods to clinical personnel and emphasizing the difference between the clinical and the statistical perspective of the data
- Reviewing the specification for laboratory and ECG data using medical expertise
John Arthur Research Fellow sponsored by Duquesne Light Company
University of Pittsburgh
01.2001 - 01.2006
- Teaching statistical courses to graduate students
- Provided statistical consulting to clinical teams from UPMC (University of Pittsburgh Medical Center)
- Statistical analysis of large datasets using STATA and MINITAB
- Sample size calculation using NCSS/PASS
Assistant Professor
Medical School, Carol Davila, Bucharest, Romania
01.1997 - 01.2001
- Lead Researcher / Principal Investigator
- Analysis of large datasets using EPIINFO, building ANOVA models for large epidemiological studies, preparing study reports for UNICEF and WHO
- Intensive interactions with multidisciplinary and multinational teams
- Active contributor to the final reports of the studies done in collaboration with CDC Atlanta
Medical advisor
United Nations Children’s Fund (UNICEF)
01.1997 - 01.2000
- Monitored sites and trained investigators on data collection and reporting
Medical residency in Pediatrics and Neonatology
Clinical Hospital “Prof. Dr. Panait Sirbu”
01.1992 - 01.1997
Education
Doctor of Medicine (MD) -
Medical School Carol Davila
Doctor of Public Health (DrPH) - Biostatistics
University of Pittsburgh
Pittsburgh, PA01.2006
Skills
Study design
R
SAS
Bayesian Statistics
All phases of drug development
Fostering Collaborative Connections
Clear Oral and Written Communication
Strategic Decision-Making
Medicine
Pediatrics
Affiliations
- American Statistical Association
- American Public Health Association
- ENAR (Eastern North American Region, International Biometric Society)
Personal Information
- Maiden Name: Constantinescu (Soaita)
- EU/Romania
- United States
- Switzerland B permit
Bibliography
Hematological Effects of Long-Term Radiation Exposure in Russian Nuclear Workers, A. I. Soaita, R. D. Day, Tamara Azizova, VDM Verlag Dr. Mueller, 2008, 978-3836440004, http://www.amazon.com/Hematological-Effects-Long-Term-Radiation-Exposure/dp/3639454715, Montelukast in the treatment of exercise-induced bronchospasm (EIB) in children with asthma, I. Cernatescu, I. Gherghina, A. I. Soaita, M. Iordachescu, European Respiratory Journal, 16, 31, 08/01/00, 307s, Nutritional aspects and behavior children under 5 years old, A. I. Soaita et. al, IOMC and UNICEF National Programme on Nutrition Surveillance, 1993-2000, Bucharest, MarLink, 973-99988-8-7, 2002, Chronic Cough Variant Asthma, European Respiratory Society Annual Congress, Geneva, Switzerland, 09/19/98 - 09/23/98, poster presentation, Complications of Central Venous Lines, Workshop, Grosshadern Klinikum, Munich, Germany, 1998, invited speaker
Hobbies and Interests
- Avid hiker enjoying in the spare time the Swiss Alps or the Romanian Carpathians with husband and dog.
- Enjoying skiing and traveling and learning about art and culture.
- Enjoying advancing German language skills.
Languages
English
Bilingual or Proficient (C2)
German
Upper intermediate (B2)
French
Intermediate (B1)
Romanian
Bilingual or Proficient (C2)
Timeline
Director, Biostatistics
ADCT
10.2021 - Current
Principal Scientist HTA
MSD
08.2020 - 10.2021
Senior Principal Biostatistician
Boehringer Ingelheim Pharmaceutical
06.2020 - 08.2020
Principal Biostatistician drug development and digital health
Boehringer Ingelheim Pharmaceutical
11.2014 - 06.2020
Director, Head of Biostatistics, Clinical Trials
Cogstate Ltd
01.2013 - 11.2014
Principal statistician
Pfizer Global R&D
11.2007 - 01.2013
Scientist/Statistician
ALZA Corporation (J&J)
01.2006 - 01.2007
John Arthur Research Fellow sponsored by Duquesne Light Company
University of Pittsburgh
01.2001 - 01.2006
Assistant Professor
Medical School, Carol Davila, Bucharest, Romania
01.1997 - 01.2001
Medical advisor
United Nations Children’s Fund (UNICEF)
01.1997 - 01.2000
Medical residency in Pediatrics and Neonatology
Clinical Hospital “Prof. Dr. Panait Sirbu”
01.1992 - 01.1997
Doctor of Public Health (DrPH) - Biostatistics
University of Pittsburgh
Doctor of Medicine (MD) -
Medical School Carol Davila
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