Senior Principal Scientist, Biostatistics

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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 discu