Director of Packaging & Innovation at Twelve, developing innovative packaging for Target products. Overseeing creative execution, client presentations, and strategic product construction.
About the role
- Director of Real-World Biostatistics at GSK focusing on drug/vaccine development using real-world data. Leading statistical efforts and mentoring junior staff in a global biopharma company.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Professional Services Director managing client integration projects and ensuring satisfaction at Estreem. Leading a department with a focus on SaaS solutions and strategic alignment.
Sr. Director, Hotels & Resorts defining and evolving Virtuoso’s global hotel portfolio strategy. Leading strategic partnerships and ensuring high - quality, differentiated network of partners.
Strategic leader for multiple accounts at Syneos Health. Focused on profitable growth, operational excellence, and exceptional customer satisfaction.
Director of Development at The Nature Conservancy, spearheading fundraising efforts across Montana's landscapes. Building relationships and managing donor strategies for conserving nature.
Senior Director of Brand responsible for developing and executing brand strategies at National Geographic Society. Overseeing brand identity and collaboration with partners while maintaining brand integrity.
Executive Director leading Cal Voices, a behavioral health advocacy agency. Responsible for strategic vision, operational oversight, and stakeholder relationships in a nonprofit setting.
Director managing McDonough Career Center, developing strategies and coaching MBA students. Fostering relationships with employers and contributing to career management services.
Senior Director responsible for orchestration strategy and intelligent automation initiatives at Fox Corporation. Driving cross - functional initiatives and modernizing service delivery models across multiple functions.
Director of Inclusion and Belonging shaping GSK's workplace culture to thrive on inclusion. Leading strategies for employee engagement and managing inclusion initiatives for organizational success.