Job Summary

The incumbent will assume a crucial role within the Global Value & Access (GV&A) team, responsible for leading and overseeing statistical activities across a diverse portfolio. This portfolio includes studies related to Alzheimer's disease (AD) dementia and various other projects. In this capacity, you will engage in collaborative efforts within the GV&A team and cross-functional partners to ensure the timely achievement of project deliverables and adherence to established timelines.

Responsibilities include, but are not limited to, serving as the statistical lead on project teams. This involves providing valuable statistical input on observational studies, actively participating in the formulation of study designs and defining study endpoints. Additionally, you will play a key role in authoring statistical analysis plans and ensuring that analyses are conducted with precision and accuracy.

Furthermore, the incumbent will be instrumental in ensuring that study results and conclusions presented in scientific publications and presentations are not only scientifically sound but also robustly supported by the statistical analyses conducted. This multifaceted role requires a deep understanding of statistical methodologies and their application in the context of non-clinical studies and related projects in AD and other therapeutic areas as needed.

Overall, the incumbent is entrusted with the leadership and effective management of statistical activities, contributing significantly to the success of a complex and dynamic portfolio.

The incumbent is expected to be a team player, and an advocate for quality, compliance, professionalism, and core corporate values at The company.

Responsibilities

Responsible to lead and manage statistical activities across a complex portfolio of neurodegenerative disorders, e.g., Alzheimer’s disease and dementia, and other projects.

Collaborate with cross-functional partners to meet project deliverables and timelines within GV&A projects related to both clinical trial setting and observational studies.

Serve as the lead statistician on project teams, offer statistical insights into clinical development plans, review and contribute to study design and define study endpoints.

Draft statistical analysis plans, ensure the appropriateness and accuracy of study design and analyses, and validate that study results and conclusions presented in scientific publications or presentations are scientifically sound and well-supported by statistical analyses.

Additionally, the position entails overseeing data and programming deliverables, with a key focus on holding vendors accountable for their responsibilities.

Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (e.g., clinical trial data, patient registries, and observational studies) to support study design and otcomes measured.

Align the specifications for data reporting, tables, listings, and figures necessary for successful publications and scientific meeting presentations.

Supervise and direct completion of all technical and operational statistical activities.

Guide internal and external teams in defining, executing, and completing statistical activities for studies and clinical programs.

Contribute to overall project planning for the portfolio.

Offer timely and pertinent advice to internal and external partners regarding statistical analysis strategies, the reliability of measurements, and the identifiability of models.

Take a lead in special projects that can benefit the portfolio, such as new methodologies, processes, technology and other tools.

Adhere to the study conduct requirements, statistical analysis principles, industry standards, and the company's Standard Operating Procedures (SOPs) as necessary.

In-depth understanding of the cross-functional roles and responsibilities involved in drug development and product life-cycle management.

Ability to travel if needed.

Attention to detail and a commitment to thorough follow-up.

Requirements:

PhD in Statistics, Biostatistics or related discipline with minimum 7 years of relevant experience in statistical analysis of biomedical data using SAS, R language or equivalent software in the biopharma industry or a related environment.

Extensive experience in biomedical statistical analysis and a proven track record of working with health science.

Proven experience in developing programs/tools to facilitate the statistical analysis of biomedical or related data.

Demonstrated excellence in complex project management, showcasing the ability to effectively oversee multiple projects and priorities.

Extensive experience collaborating with vendors to ensure the successful delivery of data and programming requirements.

Expert-level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for complex studies, particularly in clinical and observational settings.

Advanced knowledge of biostatistics best practices and tools and has shown ability to apply this to improve overall results.

Demonstrate strategic thinking in advising project teams on statistical requirements and opportunities to improve study design and project outcomes.

Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.

Strong communication and organizational skills.

Demonstrate effective communication skills in conveying project direction and status to diverse organizational levels, including leadership teams, executives, and steering committees.

Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.

Excellent written and verbal communication skills demonstrated by ability to present clear instruction/direction.

Analytical and problem-solving capabilities.

Strong scientific writing and presentation skills.