- Ensures consistency among protocols within a project, and provides certification for the protocol review check list. Works withproject team to select an appropriate study design to meet study objectives, contributes to decisions regarding data collection instruments.Conducts comprehensive review of protocol to ensure quality. Responsible for conducting research and identifying key parameters forsample size estimation.
- Independently determine appropriate statistical methodology needed in support of study objectives; develops andauthors the statistical methods section of the protocol. Responsible for randomization for routine and non-routine studies. Works withexternal partners, including contract research organizations, drug supply, and other groups, to effectively implement the randomizationschedule as planned.
- Actively participates in meetings to identify scientifically appropriate data collection instruments and database designrequirements (e.g., SAS, MS Access, Excel) to ensure that the data evaluated are free of bias, contain maximum information (minimumvariance), and satisfy analysis requirements.
- Demonstrates extended understanding of statistical concepts and methodologies. Demonstrates ability to apply statistical knowledge to solve real-world problems. Demonstrates the ability to evaluate alternative statistical approaches, to make recommendations based on sound statistical reasoning, and to influence non-statisticians to accept the analytical approach.
- Reviews identified or anticipated technical or data related issues arising in the design, conductor analysis of clinical trials or other scientific research. Approves and implements alternative analysis strategies or other recommendations toaddress these issues. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential programdevelopment of novel statistical methodology.
- Works with project team to develop strategy for data presentation and scientific arguments. Ensures consistency of data presentations and scientific/statistical arguments among reports within a project. Responsible for statistical methods andrelevant sections for major deliverables such as protocols, analysis plans, study reports and scientific publications. Responsible for accurate interpretation of analysis results. Responsible for high quality deliverables.
- Prepares oral and written reports that effectively communicate results of scientific research to the project team, AbbVie management, regulatory agencies, or individual investigators. Responsible for consistency between deliverables for the same compound and/or within same therapeutic area. Responsible for accuracy and internal consistency of report of publication, including text, tables, listings, and figures. Ensures as applicable that guidance and template format for protocol & analysis plans
- Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keepsmanagement informed on important scientific/statistical issues that may arise, in a timely manner. Provides responses to routine andnon-routine questions from clients, and independently pursues analyses suggested by the data.
- Represents Data and Statistical Sciences (DSS) or Biometrics on assigned project team(s) to provide functional area input to compound/drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area.
- Maintains technical skills and increases own knowledge of new statistical methodology or areas ofapplication through use of the scientific literature and attendance at professional meetings. Presents own statistical research or review of thestatistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics / Biometrics departmentstandards, GxP compliance, and best operating practices.
- MS or PhD in Statistics, Biostatistics or a highly related field.
- At least 4-6 years (PhD) or 8-10 years (MS) of experience in pharmaceuticaldevelopment and applied statistics/statistical consulting required.
- statistical modeling and inferential statistics; actively seeks to acquire knowledgeconcerning the use of new/novel statistical techniques and their biometric/ biopharmaceutical applications.
- Pharmaceutical or related industryexperience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in a regulated environment preferred.
Significant Work Activities: N/A
Job Type: Experienced