- Act as an epidemiology/RWE & statistical methodology expert for the assigned studies.
- Ensure that regulatory guidance on design, conduct, and reporting (e.g., ICH, EMA and FDA guidance on RWE, STROBE) and internal quality processes pertaining to statistical principles are followed for the assigned studies. Provide statistical expertise on GCP and GEP principles, and guide study team through the processes to follow.
- Serve as a technical leader in biostatistical science. Guide and supervise the selection of appropriate statistical methodologies for study design and data analysis to ensure evidence generation of the highest scientific quality. Interact with the Study Team and mentor them on statistical issues to best support the objectives.
- Apply biostatistical and quantitative epidemiological principles, techniques, and practices to develop methodology to assess alternative products to cigarettes or products beyond nicotine.
- Maintain an up-to-date knowledge of methodology and regulations.
- Oversee all study statistical aspects by reviewing and approving all statistical deliverables of the assigned studies. Bring statistical input in all study related documents and in communication with authorities. Lead CROs, track progress of statistical activities against agreed timelines to ensure that all appropriate activities have been performed and delivered on time with the expected quality.
- Provide expertise to the R&D program pre- and post- marketing studies.
- Participate in the writing, review, and update of quality documents
- MSc/PhD degree (preferred) in pharmacoepidemiology and biostatistics, or equivalent skills through demonstrated experience.
- Substantial experience in pharmaceutical, medical devices, consumer goods, or a clinical research environment is required.
- Proficiency with R or SAS is required.
- Knowledge of CDISC (SDTM, ADaM) and OMOP are an advantage.
- Interest in analyzing big datasets such as electronic medical records using machine learning algorithms is an advantage.
- Excellent interpersonal communication, organizational and leadership skills with ability to work both independently and in a team environment are required.
- Ability to mentor other team members is an advantage.
- Proficient with Excel, PowerPoint, and Word is required.
- Fluent in English, both written and spoken is required.
- Seize the freedom to define your future and ours. We'll empower you to take risks, experiment and explore.
- Be part of an inclusive, diverse culture, where everyone's contribution is respected; collaborate with some of the world's best people and feel like you belong.
- Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress.
- Take pride in delivering our promise to society: a smoke-free future.#LI-Hybrid
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Sr Scientist – Epidemiology/Real-World Evidence - , Neuchatel, Schweiz - Philip Morris International
Beschreibung
Sr Scientist – Epidemiology/Real-World Evidence (RWE) and Biostatistics – Neuchatel, Switzerland Be a part of a revolutionary change.At PMI, we've chosen to do something incredible. We're totally transforming our business, and building our future on smoke-free products.
With huge change, comes huge opportunity.
So, wherever you join us, you'll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.
It's so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that's exactly what's happening.R&D is the driving force for our bold new vision:
to replace cigarettes with a revolutionary portfolio of alternative products.
Join us and you'll have the resources, support and technology you need to break new ground and see ideas come to life.
You'll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers.
If you're creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions.
Ultimately, by delivering our smoke-free and beyond nicotine future.Your 'day to day'As a Sr Scientist – Epidemiology/RWE and Biostatistics, you will provide expertise in statistical methods, practices, and theory to design, conduct and report RWE and clinical research studies to understand the health impact of products in our portfolio (e.g., alternative products to cigarettes or others).
You will work closely with other functions to formulate questions and answer them in applying industry standards.You will translate strategic needs into innovative statistical solutions, ensuring timeliness, quality, completeness, report results according to regulatory framework, as well as interact with Clinical Research Organizations (CROs), follow-up budget and lead resources.
More specifically, you'llWho we're looking for:
What we offer Our success depends on the people who come to work every single day with a sense of purpose and an appetite for progress.
Join PMI and you too can:
