Talent.com
Director, Real-World Biostatistics
Director, Real-World BiostatisticsGSK • Waltham, MA, United States
Director, Real-World Biostatistics

Director, Real-World Biostatistics

GSK • Waltham, MA, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Overview

The Director, Real-World Biostatistics (RWB) is a key role focused on advancing strategy and methodology in the entire course of drug / vaccine development using real-world data (RWD) within the enterprise. This position requires deep biostatistical expertise, strategic insight, and supporting methodological innovation to enhance the development and commercialization of pharmaceutical products, primarily in the respiratory, immunology and inflammation research unit (RIIRU).

The Director will design and analyze RWD studies and other observational studies using cutting-edge biostatistical methodologies associated with causal inference and comparative effectiveness, clinical outcomes assessment, longitudinal and predictive modelling, and target trial emulation, while also mentoring staff assigned to these projects.

Key Responsibilities

  • Biostatistical and Methodologic Support

Lead and oversee the execution of real-world studies, ensuring methodological rigor, quality control, and regulatory adherence.

  • Create and refine statistical analysis plans, conduct complex statistical analyses, and convey findings to internal and external stakeholders.
  • Apply fit for purpose non-interventional statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.
  • Therapy Area Knowledge
  • Understand RIIRU assets to apply appropriate tools (e.g. variable definitions, code lists) and data sources, and leverage hands on RWD expertise to guide the selection and appropriate use of complex health data sets, including experience authoring technical specification documents

  • Develop in-depth knowledge on assigned assets and act as senior-level RWB consultant on matrix teams
  • Project Management and Staff Mentorship
  • Mentor junior staff, guiding and developing their capabilities through mentorship, training, and professional growth opportunities while promoting knowledge sharing, continuous learning, and an innovative and collaborative environment.

  • Lead statistical efforts for assigned projects, manage timelines, resources, quality control, and coordinate across departments (e.g. epidemiology, health economics and outcomes research, clinical).
  • Communication and Strategic Initiatives
  • Engage in strategic communication within the organization and with external audiences presenting statistical analyses and insights clearly and effectively at conferences, in publications, and during key stakeholder meetings, reinforcing the value of biostatistical contributions.

  • Methodological Development and Innovation
  • Stay informed on industry trends, incorporate emerging biostatistical methods to enhance study designs and analytics, and participate in methodological research for the development of analytical techniques.

  • Regulatory Support and Compliance
  • Provide biostatistical expertise on RWD during regulatory submissions, meeting preparations, and addressing queries to ensure alignment with regulatory standards while offering statistical guidance for organizational decision-making processes.

  • Stay informed with guidance documents from regulators to industry on the use of RWD for regulatory decision-making.
  • Why you?

    Basic Qualifications

  • Ph.D. in Statistics, Data Science, Epidemiology or related disciplines with 8+ years (or Masters plus 10+ years) of working within the pharmaceutical / biotech industry (preferably in real-world evidence, epidemiology, or health outcomes functional areas).
  • Experience in working with drug development processes and strategies, utilizing innovative statistical skills to meet project and / or business objectives.
  • Experience leading pharmacoepidemiology and / or health outcomes analytics using RWD (e.g. electronic health record; insurance claims; registries) and applying observational study design and biostatistical principles to clinical / epidemiological research.
  • Expereince in programming languages (e.g. R, Python) and applied experience with observational data.
  • Experience in working according to regulatory requirements pertaining to RWD and clinical trials.
  • Experience in managing projects, delivering results in matrixed environments.
  • Experience in methodological research with contributions to publications in real-world data analytics.
  • Preferred Qualifications

  • Experience in causal inference methodology such as propensity score based approaches, doubly-robust estimations including target maximum likelihood estimation (TMLE), principal stratification / instrumental variable approaches, methods for time-varying exposures.
  • Experience in time-to-event analysis in the setting of non-randomized studies.
  • Experience in machine learning.
  • #LI-GSK

    Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

    Why GSK?

    Uniting science, technology and talent to get ahead of disease together.

    GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas : respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

    People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

    GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

    Important notice to Employment businesses / Agencies

    GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site. All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https : / / openpaymentsdata.cms.gov /

    #J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Director • Waltham, MA, United States

    Job_description.internal_linking.related_jobs
    Director of Data and Biostatistics

    Director of Data and Biostatistics

    Gardner Resources Consulting, LLC • Lexington, MA, US
    serp_jobs.job_card.full_time
    Director of Data and Biostatistics.Master's degree in Life Sciences, Health Informatics, Biostatistics or related field.Minimum of 8–10 years of data management and / or biostatistics experience in c...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Associate Director, Analytical Manufacturing Sciences and Technology

    Associate Director, Analytical Manufacturing Sciences and Technology

    Madrigalpharma • , MA, United States
    serp_jobs.job_card.full_time
    Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis,...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, Clinical Scientist

    Associate Director, Clinical Scientist

    Clinical Dynamix, Inc. • Watertown, MA, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Associate Director, Clinical Scientist.Serve as the study lead Clinical Scientist in immunology, actively participating in program team meetings, scientific advisory boards, and data / safety monitor...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Travel Mammography Technologist - $3,148 per week

    Travel Mammography Technologist - $3,148 per week

    Medical Solutions Allied • Foxborough, MA, United States
    serp_jobs.job_card.full_time
    Medical Solutions Allied is seeking a travel Mammography Technologist for a travel job in Foxborough, Massachusetts.Job Description & Requirements. We’re seeking talented healthcare professionals wh...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    SeniorDirector, OncologyPathology Therapeutic Area Lead

    SeniorDirector, OncologyPathology Therapeutic Area Lead

    Neogene Therapeutics • Waltham, MA, United States
    serp_jobs.job_card.full_time
    Join our dedicated Research & Development team in Biopharmaceuticals R&D asa.SeniorDirector, OncologyPathology Therapeutic Area Lead. You willbe accountable for managing pathology evaluations across...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Sr. Director, Clinical Science

    Sr. Director, Clinical Science

    Apellis Pharmaceuticals, Inc. • Waltham, MA, United States
    serp_jobs.job_card.full_time
    Director, Clinical Science, is a key member of our clinical development team, contributing to and providing leadership on the development and execution of the clinical strategy for current and futu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Family Medicine Physician & Medical Director

    Family Medicine Physician & Medical Director

    Sturdy Memorial • Plainville, MA, United States
    serp_jobs.job_card.full_time
    Provide medical evaluation and treatment of all patients in an efficient, professional and thorough manner.Sturdy Health is seeking a dynamic leader to join our team as. In this pivotal role, you'll...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Lab Technician Co-Op

    Lab Technician Co-Op

    Entegris • Franklin, MA, United States
    serp_jobs.job_card.full_time
    Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue the mission. Our site in Franklin, MA is seekin...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel - Cath Lab Tech

    Travel - Cath Lab Tech

    Titan Medical (Nebraska) • Methuen, MA, United States
    serp_jobs.job_card.full_time
    WHEN YOU WORK FOR US, WE WORK FOR YOU.With Titan Medical, you gain access to thousands of travel nursing and allied health jobs across the country. You also get unmatched service.From the moment you...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Director, Statistical Programming

    Senior Director, Statistical Programming

    Cogent Biosciences • Waltham, MA, United States
    serp_jobs.job_card.full_time
    Senior Director, Statistical Programming.Be among the first 25 applicants.Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically d...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Hybrid MSAT Downstream Lead - Biologics

    Hybrid MSAT Downstream Lead - Biologics

    Oruka Therapeutics • Waltham, MA, United States
    serp_jobs.job_card.full_time
    A biotechnology firm in Waltham, MA, is seeking an Associate Director to lead downstream manufacturing processes and oversee the optimization and scale-up of biologics. The ideal candidate will have...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director, Statistical Programming

    Director, Statistical Programming

    Dyne Therapeutics • Waltham, MA, United States
    serp_jobs.job_card.full_time
    Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Histocompatibility Lab Director

    Histocompatibility Lab Director

    American Red Cross • Dedham, MA, United States
    serp_jobs.job_card.full_time
    As one of the nation's premier humanitarian organizations, the American Red Cross is dedicated to helping people in need throughout the United States and, in association with other Red Cross networ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director, AI Research and Analysis

    Director, AI Research and Analysis

    AmerisourceBergen Corporation (Cencora) • Mansfield, MA, United States
    serp_jobs.job_card.full_time
    Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, SAP Applications

    Associate Director, SAP Applications

    Lantheus • Bedford, MA, United States
    serp_jobs.job_card.full_time
    Lantheus (NASDAQ : LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcome...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Tenure Track Open Rank Faculty / Medical Laboratory Science Program Director

    Tenure Track Open Rank Faculty / Medical Laboratory Science Program Director

    UMass Lowell • Lowell, MA, United States
    serp_jobs.job_card.full_time
    The Department of Biomedical and Nutritional Sciences (BNS) at the University of Massachusetts Lowell (UMass Lowell) invites applications for a collaborative and research-active Medical Laboratory ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Veterinarian, Medical Director

    Veterinarian, Medical Director

    Wignall Animal Hospital • Dracut, MA, United States
    serp_jobs.job_card.full_time
    Veterinarian – Medical Director (Full Time).As a key leader in our hospital, you'll drive positive change and growth.Your influence will shape our vision, foster an exceptional culture, and maintai...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Med Tech

    Med Tech

    Atria Senior Living • Lincoln, RI, United States
    serp_jobs.job_card.full_time +1
    We create communities where employees thrive in their work, helping our residents thrive in their homes.Atria Senior Living's family of brands has openings for individuals looking for a career with...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted