Senior Trial Design Lead Biostatistician →
il y a 2 semaines
Company Description:
One2Treat is a forward-thinking partner for biopharmaceutical companies, founded in July 2023. Our mission is to deliver transformative insights in clinical trial design, analysis, and market access evaluations to support holistic treatment decisions, including multiple patient-relevant outcomes (e.g., quality of life) to assess the overall treatment effects of a new drug. We are dedicated to patient-centricity and leverage modern statistical methodologies and advanced software solutions to usher in a new era of personalized healthcare.
Your responsibilities will include:
- Drive interactions with customers/clients, understanding their needs in terms of clinical trial design, trial data analysis, and related interactions with regulatory agencies (i.e., FDA and EMA).
- In partnership with One2Treat’s customers, develop innovative clinical trial designs that meet regulatory agency standards and the patients’ specific needs, incorporating multiple outcomes within the primary endpoint.
- Effectively communicate complex challenges and solutions in an understandable manner to non-statistical audiences, e.g., Chief Medical Officers, medical directors, or regulatory agencies.
- Lead and oversee sophisticated statistical analyses and simulations to address complex clinical challenges across various therapy areas.
- Collaborate in the research, development, evaluation, and implementation of innovative statistical methodologies for clinical development, with a particular focus on multivariate methods and the technique of Generalized Pairwise Comparisons (GPC).
- Stay up-to-date with the latest developments in statistical methods and their applications in the clinical research industry, actively contributing to these advancements through publications, collaborations, and conference presentations.
- Proactively use your technical expertise to influence advancements and decisions in the clinical trial designs.
- Prepare, review, and approve abstracts, posters, presentations, and manuscripts for publication, ensuring the accuracy of all biostatistical elements in such documents.
- You have a Ph.D. in (bio)statistics or a comparable scientific domain (or equivalent statistical experience).
- Professional experience (at least 5 years) in biostatistics within the biopharma R&D industry, demonstrating a proven track record in clinical trial designs and statistical methodology.
- Previous experience in interactions with FDA/EMA for trial design submissions.
- Robust experience with advanced statistical methodologies and simulation techniques in the context of pharmaceutical development.
- Demonstrated ability to build relationships, understand customer needs, and provide effective solutions.
- Good communication and presentation skills, with the ability to articulate complex technical concepts to both statistical and non-statistical audiences.
- Ability to handle multiple projects in parallel, clearly managing timelines & expectations internally and externally, comfortable with dynamic environments and autonomy.
- Proficiency in R and/or Python programming.
- Willingness to travel to customer sites as needed.
Travel:
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