Clinical Trial Manager overseeing clinical studies with a focus on Atopic Dermatitis. Ensuring compliance with ICH GCP and delivering results within contractual timelines.
About the role
- Biostatistician supporting drug/vaccine projects in Late Development Statistics. Develops and coordinates biostatistical support while collaborating with research teams.
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 our Company's Research Laboratories Scientists in analyzing clinical trials, and in coordinating other statistical activities for clinical drug/vaccine projects under supervision
- Shadowing senior statisticians, serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting
- Under supervision of senior statisticians, participates in study design; performs sample size calculations and simulations to support protocol development
- Under supervision develops statistical analysis plans and determines appropriate statistical methodology for data analysis
- Participates in database design meetings and reviews relevant study documents including CRF, Data Validation Plan, and Medical Monitoring plan to ensure that the data evaluated are in high quality and satisfy analysis requirements
- Collaborates with the statistical programming staff to provide definitions, documentations, and reviews derived variables needed for planned analysis; ensures that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements
- Analyzes data and interprets results from clinical trials to meet objectives of the study protocol
- Reviews study results to ensure all the deliveries in high quality
- Under supervision of senior statisticians, prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators
- Involved in research activities for innovative statistical methods and applications in clinical trial development
Requirements
- Master’s degree or equivalent in statistics/biostatistics or related discipline
- Knowledge of statistical analysis methodologies and experimental design
- Familiar with 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
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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