This role provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or product needs at Alpha Biopharma.
Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience
Be effective in the use of relevant computational tools for study, experiment, or trial research objectives.
Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability
Ensures application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing specifications to statistical programming colleagues. Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.
Provides critical input to the statistical lead or team in optimizing study or trial designs in line with study or trial objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.
Acquires and demonstrates knowledge in pharmaceutical research and development strategies and execution. Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support.
Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidances.
Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical Operation team, and Sr. VP, Medical.
Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.
Oversee the quality of data management if it is outsourced.
Demonstrates full proficiency in systems as well as a working knowledge of other relevant computational tools as required.
Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.
Ph.D. in Statistics or related field with 5-10 years relevant experience, or Master’s in Statistics or related field with commensurate years of relevant experience.
Experience in data analysis and reporting in NDA filing