Director, Real-World Biostatistics
Company: GSK
Locations: USA – Pennsylvania – Upper Providence, Durham Blackwell Street; UK – London – New Oxford Street; USA – Massachusetts – Waltham
The Director, Real-World Biostatistics 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 providing deep biostatistical expertise, strategic insight, and supporting methodological innovation to enhance the development and commercialization of pharmaceutical products, primarily in the oncology research unit (RU).
Key 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.
Therapy Area Knowledge
- Understand RU/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 the assigned asset(s) and act as senior‑level RWD 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 use of RWD for regulatory decision‑making.
Basic Qualifications
- 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.
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.
- Excellent communication and interpersonal skills for conveying complex statistical concepts effectively.
- Fluency in written and spoken English.
- Salary and benefits information: If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $174,900 to $291,500. The US salary ranges account for location and experience. In addition, this position offers an annual bonus and eligibility to participate in our share‑based long‑term incentive program, and benefits include health care, insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.
Why GSK?
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, and we are committed to creating an environment where people can thrive. Our culture of ambition for patients, accountability for impact, and doing the right thing is the foundation for how we deliver for patients, shareholders and our people.
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. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Equal Opportunity Employer
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.
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