Responsibilities Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics. Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other scientists in the Research & Development Division to design, analyze, and coordinate clinical trial activities. Serves as the statistical representative in cross‑functional teams for clinical trial planning, execution, and reporting. Develops individual protocols and data analysis plans and determines appropriate statistical methodology. Participates in database design meetings to ensure data quality and analysis requirements are met. Collaborates with statistical programming staff to ensure all programs meet internal SOPs and external regulatory requirements. Evaluates the appropriateness of available software for planned analyses and identifies needs for developing novel statistical methodology. Analyzes data and interprets results from clinical trials to meet study protocol objectives. Independently applies basic and complex techniques to these analyses. Prepares oral and written reports to communicate results to project teams, management, regulatory agencies, or investigators. Provides responses to queries related to study design, analysis, and interpretation posed by clinical monitors, regulatory agencies, and investigators. Ensures planning and accuracy of Statistical Review Aids submitted to regulatory agencies. Participates with management in discussions with scientific personnel at regulatory agencies and investigators concerning proposed or ongoing studies. Education & Minimum Requirements PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master’s degree with a minimum of 3 years relevant experience. Required Skills & Experience Knowledge of statistical analysis methodologies and experimental design. Working knowledge of statistical and data processing software (e.g., SAS and/or R). Good oral and written communication skills. Ability to work effectively with personnel from diverse functional backgrounds. Strong interest in statistical research activities and application of novel methods to clinical trial development. Demonstrated ability to learn, be proactive and motivated, and maintain focus on detail and execution. Preferred Skills & Experience Understanding of the biology of disease and drug discovery and development. Data management, data science, numerical analysis, scientific modeling, statistical analysis, statistical research, and statistics. Benefits Salary range: $117,000.00 – $184,200.00. Annual bonus and long‑term incentive potential. Comprehensive health benefits: medical, dental, vision, and other insurance for employee and family. Retirement benefits including 401(k). Paid holidays, vacation, compassionate, and sick days. Equal Employment Opportunity Statement : As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr
Senior Scientist, Biostatistics • North Wales, PA, United States
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