Colleen McLaughlin Stern

Colleen mclaughlin stern

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location of Colleen McLaughlin SternDouglassville, Pennsylvania, United States
Followers of Colleen McLaughlin Stern409 followers
  • Timeline

  • About me

    Manager, Statistical Programming (Drug Safety & Pharmacometrics)

  • Education

    • Central bucks high school west

      2010 - 2013
      High school general studies

      Activities and Societies: National Honor Society (2012 – 2013); President of Central Bucks High School West Relay for Life Club; Women's Cross Country, Women's Track and Field Scholars Diploma; Summa Cum Laude; AP Scholar with Honors; graduated in Top 10% of class; GPA: 3.9/4.0; Advanced Placement Calculus AB, Statistics, Biology, and Macroeconomics

    • University of pittsburgh

      2013 - 2017
      Bachelor of science - bs statistics

      Activities and Societies: Lazarus Rising, National Society of Leadership and Success, and Pitt Triathlon Club Concentration in Mathematics and Substantial Biology Coursework

    • Michigan state university college of osteopathic medicine

      2021 - 2024
      Master of science - ms pharmacology and toxicology 3.903
    • University of pittsburgh

      2013 - 2017
      Bachelor of science - bs statistics
    • Michigan state university college of osteopathic medicine

      2021 - 2024
      Master of science - ms pharmacology and toxicology
  • Experience

    • University of pittsburgh

      Jan 2016 - Apr 2017
      Undergraduate teaching assistant

      - Assisted undergraduate students with introductory statistics coursework- Conducted private tutoring for written assignments and statistics software

    • St. christopher's pediatric associates

      Jul 2017 - May 2018
      Financial analyst

      - Evaluated the financial position of pediatric practices through analyzing monthly financial results in comparison to projections and forecasts- Formulated the annual operating budget for 37 pediatric practices- Collected operational data to evaluate financial trends in each practice and made recommendations for increasing productivity and revenue- Developed and maintained financial models for the CFO in order to perform monthly revenue accounting and calculate quarterly physician incentive payments Show less

    • Nuventra pharma sciences

      May 2018 - Sept 2022

      - Acted as a functional lead of the programming department and managed junior level programmers - Demonstrated skill in the use of the R programming language for data manipulation, data analysis, and data presentation- Produced and validated CDISC-compliant study outputs (SDTM and ADaM) and generated supplemental materials for data packages, including aCRFs, reviewer’s guides, and define.xml files- In collaboration with a pharmacokineticist or scientific lead, contributed to the development of appropriate CDISC datasets and TLFs for reporting of PK, PD, and safety analyses- Worked directly with clients to facilitate transfer of data in the appropriate format, to resolve data queries, and to document outcomes of client interactions- Conducted database maintenance, user acceptance testing, eCRF review, and data reconciliation- Contributed to development of best-practices and SOPs for programming activities- Supported business development and marketing activities to foster client relationshipsAs Associate PK Analyst:- Conducted non-compartmental PK and PK-PD analyses using Phoenix WinNonlin software- Consulted on design, analysis, and interpretation of clinical pharmacology studies (DDI, Food Effect, Bioequivalence/Bioavailability, SAD, MAD, etc.)- Collaborated with other consultants to prepare and review PK reports and other clinical pharmacology documents- Maintained current knowledge of regulatory guidance documents Show less

      • Associate Director, Programming (& Associate PK Analyst)

        Mar 2022 - Sept 2022
      • Manager, Programming

        Sept 2021 - Mar 2022
      • Programmer I

        Oct 2020 - Sept 2021
      • Associate, Programming

        Sept 2019 - Oct 2020
      • Specialist, Programming

        May 2018 - Sept 2019
    • Atorus

      Sept 2022 - Sept 2023

      - Supported project and account management for R package and Shiny app development projects in clinical analytics, including coordinating end-to-end software product design and documentation- Managed client financials, ensured budget adherence, and oversaw monthly revenue recognition- Oversaw and managed a team of 8 direct reports, including selection, training, development, and performance management- R package development and validation to support risk-based monitoring in clinical trials- Proficient in working with complex structures, nested function calls/callstack, and advanced understanding of {tidyverse} and base R code- Influenced cross-functional leadership and participated in business development activities- Development and maintenance of department SOPs, WIs, training, and process documentation Show less

      • Senior Manager, Analytics Engineering

        Jun 2023 - Sept 2023
      • Lead Data Solutions Engineer

        Sept 2022 - Jun 2023
    • Regeneron

      Sept 2023 - now
      Manager, statistical programming (drug safety & pharmacometrics)

      - Lead the programming and QC of analysis datasets and TFLs, following established Regeneron standards and user specifications- Represent PMX programming functions, coordinate activities with cross-functional teams, and support planning and coordination of timelines for data exchange and deliverables- Create, manage, and maintain programming specifications for analysis datasets using Regeneron tools and methodologies- Develop R tools and Shiny apps to meet departmental business needs, enhancing efficiency in clinical data checks and dynamic data visualization- Lead or perform the integration of data across studies, supporting exposure-response, popPK, and popPKPD analyses- Provide programming support for PMX deliverables related to data-driven analysis, publications, and conferences within a multidisciplinary study team- Lead the creation and validation of electronic submission requirements, including aCRF, data export files, cSDRG, ADRG, and define documents- Adhere to SOPs, guidelines, and work instructions while processing, analyzing, storing, and transferring data- Work collaboratively in a multidisciplinary study team to ensure timely and high-quality support for analysis and reporting of clinical trials- Participate in department working groups, providing input for tool development and process improvement- Provide project leadership, support resource planning, and coordinate deliverables within projects or across multiple projects- Ensure consistent documentation and maintenance of code, logs, and output in a regulated environment- Collaborate with CP and medical writing to establish the list of TFLs for CP reports based on the study SAP and CP TFL standards- Address statistical ad hoc requests from senior management and health authorities, performing exploratory analysis, as required- Independently design and test program logic, code programs, and provide guidance in implementing and executing programs Show less

  • Licenses & Certifications

    • Phoenix winnonlin 8.3 certified nca analyst

      Certara
      Apr 2023
    • Cdisc standards certification

      Cdisc
      Jul 2021
  • Honors & Awards

    • Awarded to Colleen McLaughlin Stern
      Scholars Diploma - Jun 2013
    • Awarded to Colleen McLaughlin Stern
      Summa Cum Laude - Jun 2013
  • Volunteer Experience

    • Volunteer

      Issued by CDISC on Jul 2019
      CDISCAssociated with Colleen McLaughlin Stern