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ジョブタイプ: Full-time
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仕事内容
Site Name: Home Worker - USA, Belgium-Wavre, Canada - Ontario - Mississauga, Home Worker - GBRPosted Date: Aug 8 2024
TheDirector, Real-World Analyticsuses data and methodological expertise to develop study and protocol designs and statistical analysis plans (SAPs) for the analysis of existing complex health data sets, including real-world data (RWD). This work is conducted in collaboration with Scientists in the Epidemiology organization, and other colleagues as part of matrix teams. These teams work to translate evidence needs into a robust program of studies to support appropriate regulatory approval of, access to, and evidence for GSK medicines. The work will focus primarily on the oncology therapeutic area.
Key Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.
Design and Analysis:
- Leverage expertise in RWD and methodology to propose fit-for-purpose RWD solutions with asset and research unit (RU) teams, the broader RWA community, and/or bring that expertise to a matrix team to proactively influencing evidence generation through analytics, standards, innovation, and best practices
- Lead the development and delivery of analyses of existing complex health data sets. Responsibilities include leading/contributing to protocols and/or statistical analysis plans, critically reviewing approaches and results considering design assumptions and knowledge of the data, summarizing analytic findings (including limitations) in oral or written form
- Lead specific elements (methods, design, analytics, sample/size) of protocols (or entire protocols themselves) of increasing complexity during development.
- Ensure appropriate quality control (QC) of work products
- Ensure documentation is appropriate regarding data manipulation, statistical analysis, reporting
- Author, maintain, finalize, and archive project delivery documentation for in-sourced studies in accordance with SOPs (Standard Operating Procedures) where appropriate
- Define and lead delivery of internal RWA initiatives (e.g., technical or process improvement initiatives)
- Considered an expert in one or more technical domains within GSK
- Represent RWA/GSK to the external RWD/RWE community, including contributing to GSK response to external draft regulatory or other industry-wide initiatives about RWD/RWE
- Co-author and bring statistical/methodological expertise to scientific publications
- Effectively present research results to study team and other collaborators, including results interpretation and drawing appropriate inferences based on study design/statistical methods as well as assessment of study limitations
- Effectively explain technical concepts at all levels in the organization, including senior leadership/stakeholders
- Successfully negotiate with senior management on issues which are high risk to the business
- Inform/influence TA/asset strategy through RWD/RWE expertise
- Understand RU/assets to apply appropriate tools (e.g., variable definitions, code lists) and data sources
- Current, or significant prior experience, working hands on with RWD, to guide the selection and appropriate use of complex health data sets, including experience authoring technical specification documents
- Anticipate and communicate potential problems at study or functional level and lead solutions to resolve.
- Manage projects to ensure delivery of a portfolio of high-quality work to agreed timelines
- Maintain currency with methods for the use of existing complex health datasets for research
- Develop in-depth knowledge on the assigned asset(s) and act as senior-level RWA consultant on matrix teams
- Apply innovative, fit-for-purpose methodology and approaches to solve critical problems
- Merge scientific thinking and business knowledge to identify issues, evaluate options, and implement solutions
- Proactively influence team members regarding appropriate research/statistical design and analytics delivery through various engagement forums
- Mentor team members, facilitate the development of others, and help solve day-to-day challenges
- Maintain awareness/understanding of roles of partner departments leading to enhanced contributions through collaboration.
- Demonstrate leadership within RWA through leading technical trainings, defining best practice in analytics, and fostering an environment of continued learning
- Effectively contribute as GSK representative to external industry initiatives and/or lead departmental initiatives to address key gaps
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- PhD degree + 5 years related experience, or Masters degree + 8 years of related experience, in a quantitative discipline such as epidemiology, health economics, health services research, health informatics, or biostatistics
- Experience leading pharmacoepidemiology and/or health outcomes analytics using real world data (RWD)
- Experience working applying biostatistics to clinical/epidemiological research
- Experience using statistical/analytic software (e.g., SAS, R, IHD)
If you have the following characteristics, it would be a plus:
- PhD degree in a quantitative discipline such as epidemiology, health economics, health services research, health informatics, or biostatistics, plus 7 or more years of experience working within the pharmaceutical/biotech industry (preferably in real-world evidence, epidemiology, or health outcomes functional areas)
- A good understanding of drug development processes and strategies, with proven ability to apply innovative statistical thinking to meet project and/or business objectives
- Experience leading a portfolio of projects, stakeholders and other analytic staff in a senior role
- Excellent problem-solving and analytical skills, including finding efficient and innovative solutions to challenging problems
- Enthusiasm to collaborate on a wide variety of projects across multiple therapy areas
- Familiarity with guidance documents from regulators to industry on use of RWD for regulatory decision making
- Ability to work and interact with matrix partners across the organization
- Strong problem-solving skills, ability to address conflicts/issues and make decisions to achieve results
- Ability to work with a minimum of supervision
- Excellent organizational and planning skills
- Fluency in written and spoken English to communicate effectively and articulate complex concepts to diverse audiences
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 special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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 and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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.
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締切: 20-01-2026
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