Lead Biostatistician, Innovative Trial Design

One2Treat SA; Belgique; Hybrid; USD 79,636 - 113,766; Full time

Benefits offered by this job

Health insurance

Car & mobility budget

Phone and plan

Meal vouchers

Eco vouchers

Job summary

One2Treat seeks a PhD-level biostatistician to partner with biopharmaceutical clients, shaping trial design, analysis plans, and regulatory submissions. You will deploy advanced multivariate methods and GPC-inspired approaches to optimize study power and patient outcomes.

You will collaborate with cross-functional teams, communicate complex results clearly to regulators, and publish methodological advances while contributing to a fast-growing start-up.

Qualifications

• Ph.D. in (bio)statistics or equivalent scientific domain.
• 2–5 years of professional biostatistics experience in the pharmaceutical industry.
• Strong background in advanced statistical methods and simulations.
• Ability to communicate complex statistical concepts to non-statistical audiences.

Responsibilities

• Interact with customers to understand needs in clinical trial design and data analysis.
• Develop innovative trial designs meeting regulatory standards and patient needs.
• Explain complex statistical challenges to medical directors or regulators.
• Lead sophisticated statistical analyses and simulations for multiple therapy areas.
• Collaborate on developing innovative methodologies for clinical development.
• Stay updated with statistical advances and contribute to publications and conferences.
• Influence decisions in trial designs using technical expertise.
• Prepare abstracts, posters, and manuscripts ensuring accuracy of biostatistics content.

Skills

Biostatistics

Clinical trial design

R programming

Python programming

Communication

Regulatory interactions

Education

Ph.D. in (bio)statistics

Job description

One2Treatis a forward-thinking partner for biopharmaceutical companies, dedicated to delivering transformative insights in clinical trial design, analysis, and market access evaluations to support holistic treatment decisions.One2Treatwas founded in July 2023 after four years of advanced Research and Software Development incubation within IDDI Group.

Driven by a commitment to patient-centricity,One2Treatleverages modern statistical methodologies and advanced software solutions, ushering in a new era of personalized healthcare.

Through its innovative solution,One2Treat’s visionaims to empower individual clinicians and patients to voice their treatment preferences and access personalized care tailored to their unique specific needs.

One2Treat’s missionis to enable amore holistic evaluation of treatment effects by integrating all key patient-relevant outcomes into a single comprehensive assessment of the Net Treatment Benefit. This is achieved by leveraging the Generalized Pairwise Comparisons (GPC) method, created in 2010 by Marc Buyse (One2Treat Founder).

One2Treatallows for better leveraging of the large amount of patient data collected in clinical trials and real-world evidence. This leads to more clinically meaningful statistical analysis of treatment effects, incorporating all outcomes that matter to patients. As a result, this approach significantly reduces trial sample sizes, patient recruitment timelines and speeds up innovative treatments to market.

Your responsibilities will include:

• Actively participate in interactions with customers/clients to understand 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.
• Effectively communicate complex challenges and solutions in an understandable manner to non-statistical audiences, e.g. 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.
• Keep 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.

About you:

• You have a Ph.D. in (bio)statistics or a comparable scientific domain (or equivalent experience)
• Professional experience (2-5 years) in biostatistics within the pharmaceutical industry, demonstrating a proven track record in pharmaceutical development and statistical methodology.
• 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, comfortable with dynamic environments and autonomy
• Proficiency in R and/or Python programming.
• Previous experience in interactions with FDA/EMA is a big plus.
• Willingness to travel to customer sites as needed
• You are fluent in English

Travel: <10%

Start Date: ASAP

One2Treat is driven by its 7 core values, defined by its team members. Sharing those values will be key to live the One2Treat culture, become an important contributor tot he team success and actively participate to its future growth.

One2Treat is an innovative start-up, driven by its patient-oriented purpose and sense of impact. This is also reflected in its modern and attractive package offered to all employees: a competitive salary with performance-based bonuses, health and group insurance, company car & fuel card or mobility budget (preferred option chosen by all our employees ), a phone and a phone subscription, net allowance including representation fees, meal vouchers, eco vouchers, etc.

One2Treat will offer you an important role in our quickly expanding department. You will be part of a fun and flexible work environment in which creativity, freedom and initiative are rewarded. By being part of a very ambitious, fast-growing start-up, you will have many opportunities to develop various hard and soft skills, get responsibilities, learn and develop yourself as well as your career. The position is based in One2Treat headquarter (Louvain-La-Neuve) with home-working flexibility (up to 50% after training period).

Don’t hesitate anymore, join us to revolutionize the way treatment decisions are made! Patients are waiting for this. Let’s do it all together!

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