Summary
Overview
Work History
Education
Skills
Awards and Recognitions
Languages
Projects And Key Wins
Timeline
Generic
Midhuna Vijayakumar

Midhuna Vijayakumar

Austin

Summary

Engagement Manager with 5.5 years of experience in RWE analytics, specializing in HEOR, regulatory submissions, and post-market surveillance for medical devices. Proven expertise in study design, biostatistics, and real-world data analysis (Optum, Premier, EMR/EHR). Adept at managing multimillion-dollar engagements, mentoring talent, and delivering strategic insights that drive business growth and regulatory impact.

Overview

6
6
years of professional experience

Work History

Engagement Manager

Mu Sigma
07.2023 - Current
  • Leading multiple engagements worth over $3M for a Fortune 100 healthcare organization.
  • Spearheaded business expansion efforts, generating $1.2M in revenue for RWE Analytics across HEOR studies, regulatory studies, and dashboarding projects in 2024.
  • Managed resourcing needs across the $3M engagement, ensuring optimal allocation of talent and expertise.
  • Oversaw financial operations, including SoWs and PO management, ensuring budgetary compliance and operational efficiency.
  • Strengthened client relationships through strategic engagement, delivering impactful workshops and training sessions.
  • Conducted impact assessments to evaluate and communicate the effectiveness of delivered analytics solutions.
  • Led business reviews and presented key insights to VPs and Senior Directors, influencing strategic healthcare analytics initiatives.

Lead Decision Scientist

Mu Sigma
11.2021 - 07.2023
  • Co-designed protocol studies for HEOR and regulatory submissions, ensuring scientific rigor and compliance with industry standards.
  • Conducted detailed descriptive analyses and extensive covariate assessments to drive data-driven insights for post-market surveillance and clinical research.
  • Led comprehensive studies focusing on cardiovascular medical devices and oncology (NSCLC, Heme, Bladder Cancer), supporting regulatory submissions and real-world safety assessments.
  • Advanced RWE analytics to drive data-driven decision-making for clients.
  • Optimized study methodologies by leveraging various RW databases, including Optum, Premier, EMR, and EHRs, enhancing research efficiency and outcomes.
  • Facilitated cross-functional collaboration across multiple teams to integrate diverse expertise into RWE studies, fostering a knowledge-sharing environment.

Senior Decision Scientist

Mu Sigma
11.2020 - 10.2021
  • Led post-market surveillance analytics for medical devices in the US, ensuring compliance with FDA regulatory requirements.
  • Applied advanced biostatistics techniques, including propensity score matching and covariate balancing, to enhance study accuracy and robustness.
  • Developed training programs and mentored 150+ new hires on RWE methodologies, statistical techniques, and healthcare analytics best practices.
  • Managed the hiring process, interviewing and onboarding top talent to strengthen analytics teams and drive project success.

Decision Scientist

Mu Sigma
10.2019 - 10.2020
  • Conducted real-world data analysis using large administrative claims and EHR datasets to assess treatment patterns, safety outcomes, and cost-effectiveness.
  • Supported HEOR studies with statistical modeling and data visualization techniques to communicate key findings effectively.
  • Designed and executed studies focusing on oncology and cardiovascular devices, aiding regulatory strategy and market access initiatives.
  • Partnered with cross-functional teams, including epidemiologists, statisticians, and clinicians, to deliver high-quality research insights.

Education

B. Tech - Computer Science Engineering

Sree Chitra Thirunal College of Engineering
01.2019

Skills

  • Real-World Evidence (RWE) & Real-World Data (RWD) Analytics
  • Health Economics & Outcomes Research (HEOR)
  • Regulatory Submissions & Post-Market Surveillance
  • Client Management & Cross-Functional Collaboration
  • Financial Management (SoWs, POs, Budgeting)
  • Talent Development & Corporate Training
  • Stakeholder management
  • Project planning

Awards and Recognitions

  • 4 Quarterly Awards from customers for building automations, streamlining work pipelines, quick turnaround time, and meticulous documentation for regulatory submissions
  • 1 KUDOS Award from customers for a dashboarding project
  • 3 IMPACT Awards for setting up new teams, developing talent, and successful team management
  • 3 SPOT Awards for excellence in delivery

Languages

English
Native or Bilingual
Hindi
Professional Working
Malayalam
Native or Bilingual

Projects And Key Wins

  • Led a $3M RWE engagement supporting a Fortune 100 healthcare organization's HEOR and regulatory initiatives.
  • Designed and implemented a corporate training program for 150+ new hires, improving domain expertise in healthcare analytics.
  • Developed innovative analytical frameworks for cardiovascular and oncology device studies, supporting regulatory submissions.
  • Managed financial and operational aspects of multimillion-dollar engagements, ensuring smooth execution and client satisfaction.
  • Led an RWE study using EHR data to evaluate a zero fluoroscopy workflow in catheter ablation procedures, demonstrating 100% acute accuracy, a 9-minute reduction in procedure time, and reduced radiation exposure for both patients and providers.
  • Generated evidence that supported expedited FDA approvals for 8 pipeline devices and contributed to enhanced clinical safety standards.
  • Enabled first-to-market advantage and an estimated $8M in cost savings through streamlined registry maintenance, faster procedures, and accelerated market entry.

Timeline

Engagement Manager

Mu Sigma
07.2023 - Current

Lead Decision Scientist

Mu Sigma
11.2021 - 07.2023

Senior Decision Scientist

Mu Sigma
11.2020 - 10.2021

Decision Scientist

Mu Sigma
10.2019 - 10.2020

B. Tech - Computer Science Engineering

Sree Chitra Thirunal College of Engineering

Similar Profiles

CREATE PROFILE
Midhuna Vijayakumar