Job Overview:
We are seeking Senior Principal Biostatisticians to consult on innovative and adaptive clinical trial designs, provide support for DMC/DSMB data review meetings, and analyze all parts of any clinical study. The selected candidate will provide statistical input into other disciplines' activities and participate in interdepartmental processes; provide technical solutions and advice to staff and clients on statistical processes; train less experienced biostatisticians within project activities; and be responsible for the development of Statistical Sections of Protocol including statistical methodology, statistical programming procedures, definition of derived variables, and data handling rules and data display templates.
Additional responsibilities include:
- Lead complex studies such as NDA submission or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project... meetings
- Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings
- Lead in the design and consultation on complex studies, and , multi-protocol programs. . Providing statistical oversight and attending relevant project meetings
- Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
- Perform project management activities for identified projects including resource planning, timelines, and milestone management
- Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
- Conduct overall statistical review of TFLs for complex studies prior to client delivery
- Review CRF and other study specific specifications and plans
- Perform complex sample size calculations
- Develop the statistical sections of the protocol for complex studies under the supervision of an Associate Director Statistician or above
- Provide statistical input and review of the CSR for complex studies
- Preparation and review of randomization specifications and generation of randomization schedules
- Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures
- Present and share knowledge at monthly seminars and /or team meetings and at external scientific meetings and conferences
- Attend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new business
- Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
- Represent the department during audits
Education/Qualifications:
Education:
- Master's degree, equivalent, or higher in Biostatistics or related field
Experience:
Experience Required:
- 10+ years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job
- Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
- Ability to perform sample size determination using appropriate statistical software such as NCSS PASS, Cytel EAST, StatSols nQuery, or SAS.
- Proven ability to effectively communicate statistical concepts
- Interpersonal and effective communication skills; able to communicate appropriately throughout Covance and with its clients.
- Excellent problem-solving skills, and a willingness to take ownership of decision-making.
- A good knowledge of the overall clinical trial process and of its application within Covance Clinical Development
- Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials
- Specific up-to-date knowledge of statistics as applied in clinical trials for at least one therapeutic area
