Senior Scientist, Biostatistics

Responsibilities

• Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.
• Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.
• Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
• Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
• Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.
• Independently applies and implements basic and complex techniques to these analyses.
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
• Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Involved in research activities for innovative statistical methods and applications in clinical trial development.

Requirements

• PhD or equivalent degree in statistics/biostatistics or related discipline, or a Master’s degree with a minimum of 3 years relevant 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.
• Able to work effectively with personnel with different functional background.
• Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Qualifications

• An understanding of biology of disease and drug discovery and development.

Skills

• Data Management
• Data Science
• Numerical Analysis
• Scientific Modeling
• Statistical Analysis
• Statistics

Benefits

• Medical
• Dental
• Vision Healthcare
• Retirement Benefits
• 401(k)
• Paid Holidays
• Vacation
• Caregiving and Sick Days

Pay

$117,000.00 - $184,200.00

Schedule

Hybrid Shift Not Indicated

Benefits

• Medical
• Dental
• Vision Healthcare
• Retirement Benefits
• 401(k)
• Paid Holidays
• Vacation
• Caregiving and Sick Days