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.
- 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.
- 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.