Senior Biostatistician

Covance Boston , MA 02298

Posted 3 days ago

Job Overview:

Senior Biostatistician: 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 Covance by Labcorp? 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 Senior 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:

Minimum required: Master's degree, equivalent, or higher in Biostatistics or related field

Experience:

Minimum Required:

  • 5-8 years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job

  • Experience with DMC, DSMB and provide support for DMC/DSMB data review meetings, and analyze all parts of any clinical study

  • 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 effectively communicate statistical concepts A good knowledge of the overall clinical trial process

  • Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc

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Senior Biostatistician

Covance