Process Development Senior Scientist

Role Summary

Process Development Senior Scientist responsible for designing and analyzing clinical trials and providing statistical support for drug development and regulatory submissions. This role includes contributing statistical input, reviewing study documentation, and performing quality control of protocols, randomization specifications, SAPs, and related tables, listings, and graphs. You will conduct statistical analyses of individual studies, publish applied research, and present statistical methodology at scientific meetings; stay current with developments in statistics for drug development and contribute to training within Global Biostatistics. May telecommute.

Responsibilities

• Design and analyze clinical trials, using statistical methods to support drug development and regulatory submissions.
• Provide statistical contributions, statistical review, and quality control of key design elements, protocols, randomization specifications, statistical analysis plans, tables, listings, and graphs, submission data file specifications, and other key study-related documentation; manage protocol deviations, flash memos, clinical study reports, clinical publications, and other communications.
• Complete statistical analyses of individual studies/projects.
• Publish applied research in scientific journals and books, and present on statistical methodology at external scientific meetings in the biopharmaceutical setting.
• Be familiar with statistical policy and strategies; stay abreast of the latest developments in statistics in drug development and contribute to scientific advances in the field.
• Communicate the role of Global Biostatistics and contribute to statistical training within Global Biostatistics.
• Assist in the review of policies, SOPs, and other controlled documents; assist with study and systems audits conducted internally and externally.
• Use SAS and R to produce comprehensive tables and graphs to summarize outcomes.
• May telecommute.

Qualifications

• Designing experiments or clinical trials to meet project requirements, regulatory standards, or scientific objectives, including development of protocols and Statistical Analysis Plans (SAPs).
• Utilizing SAS, R or other statistical software to analyze clinical study data or observational study data.
• Assessing, implementing or developing new statistical methods to improve efficiency and validity of clinical trials.
• Utilizing R or other statistical software to perform simulations to evaluate operating characteristics of analytic methods or design options.
• Utilizing programming software to develop tools to evaluate methods or statistical designs including creation of software packages or interactive tools.
• Performing causal inference analyses on clinical trial or observational datasets to address potential biases and confounding factors.
• Employ trial design strategies to mitigate challenges such as high dropout, skewed distributions, missing data, and confounding, including the use of robust regression and imputation.

Education

• Master’s degree or foreign equivalent in Statistics, Biostatistics or related field.

Skills

• SAS
• R
• Statistical analysis
• Data visualization