Sr. / Director, Biostatistics
Responsibilities:
- Responsible for applying relevant statistical methods to the practice of clinical data summaries and interpretations
- Lead and mentor junior team members
- Represent Company statistical function to work with Health Authorities and Key Opinion Leaders as needed
- Provide strategic and technical input into drug development plan; work with cross-functional team to design and operationalize clinical studies; provide statistical input in the evaluation, interpretation, and preparation of study results
- Be accountable and responsible for statistics deliverables such as statistical analysis plans, clinical study reports, protocols, TLGs, publications, congress presentations, etc.
- Select, manage, and supervise CROs.
- Create standard SAS programs and macros to generate report-quality summary tables, listings and graphical presentations of clinical data.
- Prepare programs for creating analysis data sets and associated tables, listings, and graphs used for interim analyses, final analysis, press releases, and presentations and publications
- Understand CDISC structure for datasets and ability to merge relational database records
- Review and provide appropriate input to the design of Case Report Forms or Electronic Data Capture screens
- Review clinical data for inappropriate, incorrect, and/or inconsistent values
- Develop and program electronic checks to assist data management and clinical with monitoring and scrubbing of clinical trial data as needed
- Assist with resolution of unique queries that may arise during the data management and statistical analysis process
- Provide ad-hoc data listings and summary information as requested by members of the BDM and Clinical groups
- Conduct ad hoc and exploratory analysis to unveil signals contained in clinical trial data
- Lead and participate in developing and maintaining relevant BDM processes to ensure quality of study data and accuracy of statistical outputs
- Perform quality control with respect to the data to be analyzed and the programs to be used for the analysis
- Define processes and perform additional (alternative) quality checks focusing on key efficacy and safety endpoints to ensure validity of data and accuracy of analyses.
- Continue to improve the quality process to ensure the growing requirement of data and output validations
- May be responsible for supervising and mentoring direct report(s)
- Managing / supporting the preparation of data package for NDA and other regulatory submissions
- Adhere to the standard computer directory and file structures used within the BDM group and Clinical department
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