Principal Biostatistician, FSP (Remote)
These permanent, remote opportunities can be worked from anywhere in the U.S. or Canada. #LI-REMOTE
Are you ready to discover your extraordinary potential at Labcorp Drug Development? A career here provides the unique chance to create a lasting impact and difference in patients' lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy, innovative & collaborative work place, along with access to comprehensive benefits. Your work is meaningful, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning. Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.
We are seeking Principal Biostatisticians to lead large global or other major projects, analyze all parts of any clinical study, and provide planning on multiple clinical studies from multiple clients including tracking project activities and project time management. 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; supervise and train less experienced biostatisticians within project activities; and be responsible for the development of Statistical Analysis Plans including statistical methodology, statistical programming procedures, definition of derived variables, and data handling rules and mockups.
Essential Job Duties:
- Lead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
- Perform project management activities for identified projects including resource planning, timelines and milestone management
- Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants
- Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
- 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 under the supervision of more senior statistical staff
- Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
- Provide statistic 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.
- Master's degree, equivalent, or higher in Biostatistics or related field
- Five years of postgraduate experience in the application of statistics to clinical trials for employees with a PhD in statistics subject; 8 years of postgraduate experience in the application of statistics to clinical trials for employees with an MA/MS in statistics subject
- Oncology experience needed
- Experience as study level including expereince amending SAP, updating TLF mock shells, reviewing ADaM data sets and TLFs, supporting the CSR etc.
- 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
- Proven ability to effectively communicate statistical concepts
- A good knowledge of the overall clinical trial process and of its application within Labcorp Drug Development
- Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials
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