Duties and responsibilities:
• Reviews study protocols, develops statistical analysis plans and the analysis specifications for the programming implementation of the statistical analyses
• Provides statistical input into data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure that they support the protocol specified goals and statistical analyses
• Develops statistical programs, as needed, in support of ad-hoc requests, manuscripts and presentations and provides statistical review of scientific reports and publications
• Collaborates with other functional areas on project deliverables and timelines within area of responsibility
• Provide oversight of CRO deliverables within area of responsibility to ensure quality and accuracy
• Provide timely feedback on resource needs within area of responsibility to supervisor regarding statistical deliverables
• Adhere to the company and department SOPs and working practices
Candidate Skills & Experience:
• PH.D. in Statistics or Biostatistics with a minimum of 1 year of experience in the pharmaceutical or biotech industry, or Master with a minimum of 2 years of experience.
• Up-to-date expertise/knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling and analysis
• Advanced knowledge of the SAS programming language; knowledge of R or similar language a plus
• Ability to build strong relationship with peers within the Biometrics department and cross functionally
• Ability to work with moderate supervision
• Strong organizational and time management skills, and the ability to prioritize multiple deliverables and ad-hoc requests.
• Excellent communication skills