- Participate in strategic planning and develop optimal clinical development plans with cross-functional drug development teams
- Oversee all the studies for one compound to ensure the consistency of statistical work standards as the project statistical leader
- Responsible for writing statistical methodology section of the protocol, including sample size calculation
- Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS/ISE
- Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities
- Direct the activities of internal and external statistical programmers, to ensure the intended analyses are performed, and analysis data sets and their specifications are in place, following STDM standards.
- Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents.
- Participate in operations meetings, project team meetings, and address issues related to biostatistics.
- Support and participate in the preparation of study reports, regulatory submissions, and annual safety update reports.
- Perform ad hoc analysis and data validation.
- in statistics/biostatistics with minimum 8 years of biopharmaceutical statistics experience; Master's degree in statistics or biostatistics with a minimum of 10 years of experience with specific experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry.
- Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
- Experience in Biostatistics, SAS programming, and clinical data management in a regulated clinical research environment
- Knowledge of missing data handling, multiple comparisons, and simulation techniques.
- Experience in organizing regulatory submissions such as BLA, NDA, sNDA, and MAA submissions.
- Good working knowledge of ICH, FDA and GCP regulations and guidelines
- Strong leadership skills and team work spirit.
- Experience in the neurology/cardiovascular therapeutic areas desirable