Senior Scientist, Biostatistics, Early Development Statistics

Job Description

Our company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our company’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Our company's Research Laboratories is a true scientific research facility of tomorrow and will take our company's leading pharmaceutical R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Responsibilities:

• Provide data analytic solutions for real-world tasks, focusing on complex data types including images, signals, text, omics, etc.

• Apply sound scientific principles and data analytic methods to pharmaceutical Research and Development (R&D) projects.

• Understand customer requests and effectively communicate analysis results to customers.

• Perform statistical analysis to support biological and vaccine clinical assays.

• Author and review detailed statistical reports suitable for submission to health regulatory authorities, including the US FDA and international agencies.

Primary activities:

• Serve as data analytic representative in cross-functional teams for pharmaceutical R&D. 

• Collaborate with people from diverse backgrounds and expertise, including research scientists, clinical scientists, regulatory experts, IT specialists, etc.

• Identify opportunities to add value to different phases of pharmaceutical R&D projects.

• Identify potential data and data analysis-related problems, propose solutions, and implement them.

• Analyze data and interpret results. 

• Communicate analysis results effectively to audience with diverse background and expertise through both oral presentations and written reports.

• Provide responses to data and analysis-related queries from research scientists, clinical scientists, and regulatory agencies. 

• Engage in AI/ML and statistical methodology research.

• Author and review detailed statistical reports, as well as respond to inquiries from health regulatory authorities.

Education Minimum Requirement:

• Ph.D. or equivalent degree in Statistics/Biostatistics/Data Science/Computer Science or related disciplines. OR

• Master's degree with a minimum of 4 years of relevant work experience.

Required Experience and Skills:

• Solid knowledge of AI/Machine Learning and statistical principles and methodologies.

• Demonstrated strong programming skills, particularly in Python and R languages.

• Strong oral and written communication skills.

• Ability to work well both independently and collaboratively.

• Demonstrated interest in methodology research and the application of novel methods to real-world problems.

• Ability to learn, be proactive and motivated, and consistently focus on details and prompt execution.

• Ability to collaborate with scientists and work effectively on multidisciplinary teams.

• Ability to work in a regulated environment and maintain a high level of attention to detail.

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