What you'll be doing:
- Provide statistical expertise in the assigned projects and clinical programs
- Guide the project teams using the most efficient study design by considering the regulatory agencies requirements for the country and regions the compound will be submitted to and help to maximize the success of the drug product.
- Participates in protocol development and prepares statistical sections in the protocol, Statistical Analysis Plan (SAP), and Clinical Data Presentation Plan (CDPP)
- Ensures consistency in data collections, derived data definitions, statistical analyses and result interpretations throughout the drug development.
- Lead/participate in the planning and analysis of integrated efficacy and safety data and ensures that efficacy and safety summaries meet regulatory requirements.
- Provide input into the entire clinical development plan to ensure that the overall strategy can deliver the pre-specified target product profile and that proposed studies have appropriate clinical trial designs.
- Guide CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definitions, analysis methodologies, and accuracy of analysis results.
What we're looking for:
- PhD in statistics, biostatistics, or other related field with high statistical content
- 5+ years of experience working in the pharmaceutical industry
- Knowledge of ICH/EMEMA/FDA guidelines
- Ability to innovate creatively in a clinical study design setting
- Ability to communicate with clarity and influence
- Ability to effectively collaborate and influence other functions
- Demonstrated ability to serve effectively as a team leader
- Experience in regulatory interactions and submissions
- Comprehensive knowledge of statistical methods and applications in study design and analysis
- Programming skills in SAS
- Experience in implementation of CDISC, SDTM, and Adam datasets
- Knowledge of statistical software package such as nQuery, EAST, etc.
