Senior Principal Scientist, Biostatistics

Johnson Johnson; Beerse; Sur place; EUR 120 000 - 150 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine is recruiting for a Senior Principal Scientist, Biostatistics to join the Statistics & Decision Sciences team based in Beerse, Belgium.

You will lead and support broad implementation of innovative statistical approaches across the development portfolio, collaborating with partners from clinical teams, QA, and external CROs; you will mentor team members and stay at the forefront of adaptive designs and model-based methods.

Qualifications

• Ph.D. in Statistics or related field with relevant experience, or Master's in a related discipline.

Responsabilités

• Develop and implement innovative statistical designs and methods across drug development.
• Plan, run, and summarize simulation studies to evaluate operating characteristics of designs.
• Collaborate with statisticians, clinical teams, and other partners to advance methods.
• Engage with external CROs and participate in IDMCs for trials with interim analyses.

Connaissances

Biostatistics

Formation

Ph.D. in Statistics or related field

Description du poste

Job Function

Data Analytics & Computational Sciences

Job Sub Function

Biostatistics

Job Category

Scientific/Technology

All Job Posting Locations

Beerse, Antwerp, Belgium

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Johnson & Johnson Innovative Medicine is recruiting for a Senior Principal Scientist, Biostatistics to join the Statistics & Decision Sciences team. This position will be based at Beerse, Belgium.

You will be responsible for leading and supporting broad implementation of innovative statistical approaches across the development portfolio. Engage key partners from different areas, help identifying potential hurdles for broader use of innovation in drug development and finding solutions for them.

Innovation

Develop and implement innovative approaches, participating in their hands‑on implementation through direct interactions with statisticians, clinical teams, and other relevant partners. This involves but is not limited to developing/identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods under a range of scenarios; and participating in the implementation of the selected approaches by engaging in protocol and SAP write-up.

See opportunities for innovation, participate in program reviews/discussions; interact directly with statisticians, TA (Therapeutic Area (TA)) representatives within SDS, and other QS scientists for early identification of opportunities for innovative approaches.

Impact

Collaborates with external consultants and qualified CROs to provide support in the development and implementation of innovative methods and designs. Participate in IDMCs for trials with unblinded interim analysis related to innovative approaches (e.g., adaptive designs), as needed.

Collaborate in talent identification, hiring and development for the Statistical Modeling, Methodology, and Consulting (SMMC) group.

Help ensure proper knowledge and awareness of innovative methods and designs; help identify, develop, organize, provide and/or arrange training and presentations on innovative approaches across the R&D organization (including statisticians, pharmacometricians, clinicians, and other partner groups) to ensure awareness and adequate knowledge about these methods. Keep up‑to‑date knowledge of designs and analysis methods for clinical trials, including adaptive develop, model‑based methods, etc.

Maintain active external visibility and impact, engage in external collaborations within professional associations (e.g., ASA, IBS, SCT, ISoP, ISCB, PSI, EFPSI), participating in working groups, program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals. Influence the pharmaceutical industry and regulatory environments, by engaging in scientific advocacy working groups and committees.

Participate in meetings with Health Authorities to discuss innovative designs and analysis methods, as needed.

Experience Requirements

Ph.D. in Statistics or related field with relevant experience, or Master's in