Principal Biostatistician (Remote)

<h2>Job Overview:</h2><p style="margin-bottom: 0in;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><strong>Principal Biostatistician, FSP: Remote</strong></span></p><p style="margin-bottom: 0in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif; color: #000000;"> </span></p><p style="margin-bottom: 0in;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif; color: #000000;">These are permanent, remote opportunities can be worked from anywhere in the U.S. or Canada. #LI-REMOTE</span></p><p style="margin-bottom: 0in;"> </p><p style="margin: 0in;"><span style="color: black; font-family: 'Arial',sans-serif; font-size: 12pt;">We are seeking 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.</span></p><p style="margin: 0in;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;"> </span></p><p style="margin: 0in;"><span style="color: black; font-family: 'Arial',sans-serif; font-size: 12pt;">Additional responsibilities include:</span></p><ul><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">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</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings</span></li><li style="margin: 0in; color: black;"><span style="color: windowtext; font-family: 'Arial',sans-serif; font-size: 12pt;">Lead in the design and consultation on complex studies, and , multi-protocol programs. Providing statistical oversight and attending relevant project meetings</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Perform project management activities for identified projects including resource planning, timelines, and milestone management</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Perform complex statistical analyses, quality check statistical analyses developed by other statisticians</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Conduct overall statistical review of TFLs for complex studies prior to client delivery</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Review CRF and other study specific specifications and plans</span></li><li style="margin: 0in; color: #000000;"><span style="color: black; font-family: 'Arial',sans-serif; font-size: 12pt;">Perform complex sample size calculations under supervision of senior statistical staff</span></li><li style="margin: 0in; color: #000000;"><span style="color: black; font-family: 'Arial',sans-serif; font-size: 12pt;">Develop the statistical sections of the protocol for complex studies under the supervision of </span><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">an Associate Director Statistician or above</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Provide statistical input and review of the CSR for complex studies</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Preparation and review of randomization specifications and generation of randomization schedules</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">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</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Present and share knowledge at monthly seminars and /or team meetings and at external scientific meetings and conferences</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Attend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new business</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Represent the department during audits </span><span style="color: windowtext; font-family: 'Arial',sans-serif; font-size: 12pt;"> </span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0in;"><span style="color: black; font-family: 'Arial',sans-serif; font-size: 12pt;">Minimum Required: </span></p><ul><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Master’s degree, equivalent, or higher in Biostatistics or related field</span></li></ul><h2>Experience:</h2><p style="margin: 0in;"><span style="color: black; font-family: 'Arial',sans-serif; font-size: 12pt;">Minimum Required:</span></p><ul><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">8+ years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">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 </span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Ability to perform sample size determination using appropriate statistical software such as NCSS PASS, Cytel EAST, StatSols nQuery, or SAS. </span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Proven ability to effectively communicate statistical concepts</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Interpersonal and effective communication skills; able to communicate appropriately throughout Covance by Labcorp and with its clients.</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Excellent problem-solving skills, and a willingness to take ownership of decision-making.</span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">A good knowledge of the overall clinical trial process and of its application within Covance by Labcorp Clinical Development </span></li><li style="margin: 0in; color: black;"><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials </span></li><li style="margin: 0in; color: #000000;"><span style="color: black; font-family: 'Arial',sans-serif; font-size: 12pt;">Specific up-to-date knowledge of statistics as applied in clinical trials for at least one therapeutic area</span><span style="font-family: 'Arial',sans-serif; font-size: 12pt;">.</span></li></ul>