Elena Dudukina

Elena Dudukina

Consultant/Pharmacoepidemiologist

Danish Medicines Agency, Data Analytics Center

About me

I conduct research in pharmacoepidemiology and women’s health. I have experience in observational RWE/PAS studies of drugs and vaccines, especially, in pregnancy. I am passionate about causal inference methods and R stats.

Interests

  • Causal Inference
  • Pharmacoepidemiology (drug utilization, drug safety and efficacy)
  • Women’s health and reproductive epidemiology
  • R stats

Experience

 
 
 
 
 

Special consultant/Pharmacoepidemiologist

Danish Medicines Agency, Data Analytics Centre

Sep 2023 – Present Denmark

Responsibilities and tasks include:

  • Consulting on international RWE projects and large EMA international pilots (e.g., European Health Data Space use case)
  • Providing expertise on the prospectively collected administrative and healthcare database studies incl. regulatory assessment of RWE PASS studies
  • Leading role on internal taskforce for Danish registry data conversion to common data model
  • Design, execution and reporting of real-world evidence (RWE) pharmacoepidemiologic studies
  • Providing scientific and methodological input on various aspects of study design and conducted or planned analyses
  • Writing of study protocols, statistical analysis plans, study reports, scientific manuscripts
  • Developing presentations to conferences and stakeholder meetings
  • Project management and communication with internal and external stakeholders
  • Research student supervision and daily support
  • Organisation and planning of a yearly speaker event
  • Analytical support of ongoing projects and applied statistical data analyses for regulatory purposes
 
 
 
 
 

Clinical Specialist/postdoc

Aarhus University Hospital, Department of Clinical Epidemiology

Sep 2021 – Aug 2023 Denmark

Responsibilities include:

  • Design, execution and reporting of real-world evidence (RWE) pharmacoepidemiologic studies
  • Writing of study protocols, statistical analysis plans, study reports, scientific manuscripts
  • Providing scientific and methodological input on various aspects of study design and conducted or planned analyses
  • Creating abstracts, manuscripts and presentations
  • Project management

Skills include:

  • Using time-to-event modelling (Cox proportional hazards regression, Fine-Gray subdistribution hazard model), logistic regression, log-binomial regression, propensity-score based adjustment methods
  • Teaching incl. epidemiological designs and methods to Masters students overall covering > 200 hours
  • Data management, including complex cohort and variables ascertainment from various health and administrative databases, and statistical analyses involving PS adjustment methods (IPTW, ATT weighting, fine PS stratification, PS weighting, PS stratification, PS matching)
 
 
 
 
 

PhD in Epidemiology

Aarhus University, Department of Clinical Epidemiology

Jun 2018 – Jun 2021 Denmark

Responsibilities include:

  • Participating in development of the research protocols and statistical analyses plans for own and collaborative projects
  • Independent data management, incl. cohort and variables ascertainment from various Danish health and administrative databases
  • Statistical analyses
 
 
 
 
 

MSc in Biomedicine

Radboud University

Jan 2015 – Jan 2017 the Netherlands
MSc level courses in clinical epidemiology, epidemiology of infectious diseases, and statistics. Applied training during 6-months internship at Radboudumc and another 6-months external internship at Rijksinstituut voor Volksgezondheid en Milieu (RIVM).
 
 
 
 
 

MD (Preventive Medicine

First Moscow State Medical University

Jan 2008 – Jun 2015 Russia
Specialization in Medicine and Public Health; graduated with honors (magna cum laude)

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