SENIOR PRINCIPAL STATISTICAL SCIENTIST

Key Skills

Apache Hadoop, C Programming, C++, Data science techniques, Java Programming, Machine learning techniques, MapReduce, Python Programming, PyTorch, R Programming, Scala Programming, SQL, TensorFlow

Job Description

The Senior Principal Statistical Scientist is responsible for providing statistics expertise and strategic drug development leadership for the most complex and high impact clinical development projects, portfolio-wide initiatives, research applications, development science applications, and/or product manufacturing applications. Their accountabilities typically extend to representing all Biometrics functions on highly visible global development teams and other cross-functional expert groups across the Pharma Development organization.

Accountabilities

Clinical Development

• Operates at the Global Development Team level, either as Project Lead Statistician or as the sole representative for Biometrics functions on a Global Development Team.
• Provides statistical leadership for clinical development projects, including providing strategic input into clinical development plans, target product profiles, and integrated evidence plans.
• Directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies within the project, including activities to support personal healthcare strategy and governance committee decision making.
• Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling.
• May serve as lead statistician for one or more study management teams, with the incumbent responsibilities and accountabilities.
• Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation.
• Company Biostatistics lead for Health Authority interactions.
• Oversees the deliverables from Statistical functional CROs and FSPs and provides leadership, oversight and guidance to CRO statisticians representing Biostatistics at all levels.
• Serves as member of business development due diligence efforts.
• Proactively advises teams and functions on overall data strategy and the best application of statistical methods including advanced analytics and relevant data types.
• Leads and drives partnerships with other analytical functions, focusing on the application of methods that are appropriate to the data type and analysis context.

Functional Area

• Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc.
• Leads Biostatistics and cross-functional initiatives.
• Leads the development of functional processes.
• Recognized expertise in clinical trials and statistical methodology for a clinical indication and/or statistical methodology for specialized applications.
• Mentors statisticians on request.