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Company

BioSpace · 8 hours ago

Senior Manager, Statistics

California, United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

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Comp. & Benefits

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Responsibilities

Support regulatory submission and product life-cycle management strategy planning and implementation.

Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs.

Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation).

Work independently to implement sound statistical methodology in scientific investigations.

Represent the function on project team(s) to provide functional area input to asset development.

Lead in identifying scientifically appropriate data collection instruments.

Provide programming specifications for derived variables and analysis datasets.

Guide Data Science and other functions in preparing for database lock.

Ensure accuracy of data released for statistical analysis.

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.

Ensure appropriate interpretation of statistical deliverables in collaboration with other functions.

Collaborate in publication of scientific research.

Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.

Work collaboratively with multifunction teams per agreed timelines.

Clearly explain statistical concepts to non-statisticians.

Provide responses to questions from clients and pursue analyses suggested by data under supervision.

Support communications between assigned product team(s) and functional management.

Build/drive cross functional relationships and collaboration.

Qualification

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StatisticsBiostatisticsStatistical analysisClinical trialsData presentationDrug developmentProject managementPharmaceutical knowledgeCross-functional collaboration

Required

MS (with 8+ years of experience) or PhD (with 4+ years of experience) in Statistics, Biostatistics, or a highly related field.

High degree of technical competence and effective communication skills, both oral and written.

Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.

Able to manage project timeline and quality of deliverables.

Able to build strong relationship with peers and cross-functional partners to achieve higher performance.

Pharmaceutical or related industry knowledge desired, including experience and understanding of drug development and life-cycle management in the regulated environment.