Principal Biostatistician

**Principal Biostatistician, DMC/ DSMB (Remote): These permanent, remote opportunities can be worked from anywhere in the U.S. or Canada regions #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 workplace, 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.**:
**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 under supervision of senior statistical staff**:

- ** 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**:
**Experience Required**:

- ** 8+ 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 Labcorp and with its clients.**:

- ** Excellent problem-solving skills, and a willingness to take ownership of decision-making.**:

- ** 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.**:
**Minimum Required**:
**Education: Master’s degree, equivalent, or higher in Biostatistics or related field**:
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, gene