Manager - Statistics (Hybrid)

Responsibilities

• Provide expertise to design, analysis and reporting of clinical trials or other scientific research studies.
• Independently develop protocols and/or statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation) with details for programming implementation.
• Implement sound statistical methodology in scientific investigations.
• Identify scientifically appropriate data collection instruments.
• Identify and report data issues or violations of study assumptions.
• Provide programming specifications for derived variables and analysis datasets.
• Partner with Data Science in preparing for database lock.
• Independently perform statistical analyses as per the analysis plan.
• Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines.
• Identify and anticipate issues arising in the study design, conduct and propose scientifically sound approaches.
• Evaluate appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology.
• Develop strategy for data presentation and inference.
• Collaborate in publication of scientific research.
• Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided.
• Work collaboratively with multifunction teams.
• Clearly explain statistical concepts to non-statisticians.
• Provide responses to questions, and pursue analyses suggested by data.
• Support communications between assigned product team(s) and functional management.
• Build/drive cross-functional relationships and collaboration.

Qualifications

• Minimum Qualifications: MS (with 6+ years of experience) or PhD (with 2+ years of experience) in Statistics, Biostatistics, or a highly related field.
• Experience performing statistical computations and simulations.
• Pharmaceutical or related industry knowledge desired, including experience and understanding of drug development and life-cycle management in the regulated environment.