Senior Trial Design Lead Biostatistician

One2Treat; Town of Belgium (WI); On-site; USD 79,636 - 125,142; Full time

Benefits offered by this job

Competitive salary with bonuses

Health and group insurance

Company car & fuel card or mobility预算

Phone and phone plan

Net allowance including representation

Meal vouchers

Eco vouchers

Job summary

One2Treat in Belgium seeks an experienced biostatistician to lead statistical analyses and innovative trial designs across multiple therapy areas. You will work closely with biopharma clients and regulatory agencies, applying complex methods including multivariate analyses and Generalized Pairwise Comparisons (GPC).

The role requires a Ph.D. in (bio)statistics with 5+ years in biostatistics, strong programming in R/Python, and excellent communication skills to convey technical concepts to both

Qualifications

• PhD in (bio)statistics or equivalent scientific domain.
• Professional biostatistics experience in biopharma R&D (5+ years).
• Experience with interactions with regulatory agencies (FDA/EMA).
• Strong statistical methodology and simulations expertise (multivariate methods, GPC).
• Excellent communication and ability to convey complex concepts to diverse audiences.

Responsibilities

• Lead statistical analyses and simulations for complex clinical challenges across therapy areas.
• Develop innovative trial designs meeting regulatory standards and patient needs.
• Communicate complex statistical concepts to non-statisticians (CMOs, medical directors, regulators).
• Prepare abstracts, posters, presentations and manuscripts with biostatistical accuracy.
• Travel to customer sites as needed (<10%).

Skills

R

Python

Education

PhD in (bio)statistics

Job description

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 i.e. include multiple patient-relevant outcomes (e.g. including the quality of life) to assess the overall treatment’s effects of anew 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, 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, 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: <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 to the team success and actively participate to its future growth.

• 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 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 organization. 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, take responsibilities, learn and develop yourself as well as your career. Last, but not least, you will have a direct contribution to the transformation of the clinical research industry, from a one-dimensional way to assess treatment effect towards a multi-faceted, patient-relevant assessment of new treatment effects.

The position is based in One2Treat headquarter (Louvain-La-Neuve) with home-working flexibility (up to 50% after training period).