Director, Real-World Biostatistics
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Massachusetts, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $174,900 - $291,500 per year
Job Level
Lead
Tech Stack
Python
About the role
- 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.
- Understand RU/assets to apply appropriate tools (e.g., variable definitions, code lists) and data sources and leverage hands on with RWD expertise to guide the selection and appropriate use of complex health data sets, including experience authoring technical specification documents.
- 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.
- 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.
- 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.
- 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.
Requirements
- Ph.D. in Biostatistics, Statistics, 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 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
- Experience 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.
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biostatisticsstatistical analysisobservational study designpharmacoepidemiologyhealth outcomes analyticsprogramming languagesRPythonregulatory requirementsmethodological research
Soft skills
mentorshipstrategic communicationcollaborationknowledge sharingcontinuous learningtrainingprofessional growthleadershipproject managementdata interpretation
Certifications
Ph.D. in BiostatisticsPh.D. in StatisticsPh.D. in EpidemiologyMasters in related disciplines