UBC · 6 hours ago
Sr Scientist - Epidemiology/RWE & Biostatics - Europe
United States
Full-time
Remote
Senior Level
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Responsibilities
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.
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.
Qualification
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Required
Substantial experience in pharmaceutical, medical devices, consumer goods, or a clinical research environment is required.
Proficiency with R or SAS is required.
Excellent interpersonal communication, organizational and leadership skills with ability to work both independently and in a team environment are required.
Proficient with Excel, PowerPoint, and Word is required.
Fluent in English, both written and spoken is required.
Preferred
MSc/PhD degree (preferred) in pharmacoepidemiology and biostatistics, or equivalent skills through demonstrated experience.
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.
Ability to mentor other team members is an advantage.
Company
UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access.
Founded in 2003
1001-5000 employees
H1B Sponsorship
UBC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (6)
2021 (5)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$0.04M2017-11-27Acquired
2010-08-13Series Unknown· $0.04M
Leadership Team
Bekki Brown
Chief Operating Officer
Brett Huselton
SVP, Chief Business Officer
Company data provided by crunchbase
