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Associate Director, Biostatistics (Remote)

Laboratory Corporation of America Holdings (Covance)

Durham, North Carolina, United States

<h2≥Job Overview:</h2≥<p style="margin: 0in;"≥<span style="color: black; font-family: 'Arial',sans-serif; font-size: 12pt;"≥We are seeking Associate Director, Biostatistics 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 style="margin-top: 0in;"≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Represents the department in capabilities presentations in order to win all client relationships.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Participates in proposal development for standalone, small programs and/or new drug applications (NDAs) and in bid defense.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Oversee 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: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Advise on and coordinate biostatistical aspects of submissions to regulatory authroities; participate in presentations to regulatory reviewers.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Oversee all DMC processes; Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Provide statistical guidance in the development of Clinical Development Plans as well as complex Statistical Analysis Plans; perform senior review of statistical analysis plans developed by other statisticians</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Review complex statistical analyses, quality check statistical analyses developed by other statisticians</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Monitors projects quality, timelines and budgets to foresee and correct issues and assure project expectations are met.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Work to ensure that resources are used efficiently, and team is well utilized.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Carry out line management responsibilities for assigned staff, including Performance Management and Development activities, disciplinary procedures and administrative activities.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Responsible for staff career growth and development.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Provides statistical and technical support to team members.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Develop and maintain close working relationships with the management of other disciplines, particularly those that interact with the department.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Provide training and guidance on biostatistics-related topics within the department and to other disciplines.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Participates in internal and client audits, and regulatory inspections.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Proactively lead, review and amend departmental processes and documentation.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Establish and maintain client relationships and implement appropriate action plans based on client feedback.</span≥</li≥<li style="margin: 0in; color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Organize team meetings to keep employees informed of new developments and to strengthen team spirit.</span≥</li≥</ul≥<h2≥Education/Qualifications:</h2≥<p style="margin: 0in;"≥<span style="color: black; font-family: 'Arial',sans-serif; font-size: 12pt;"≥Education: </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;"≥Experience Required:</span≥</p≥<ul≥<li style="color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Minimum 12 + years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job, preferably with at least 2 years of line management experience.</span≥</li≥</ul≥<ul≥<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 and with its clients.</span≥</li≥</ul≥<ul≥<li style="color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Strong supervisory skills, and ability to organize their own and others' work.</span≥</li≥</ul≥<ul≥<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≥</ul≥<ul≥<li style="color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Full knowledge of the interactions required by a biostatistician throughout the lifespan of a trial; a substantial knowledge of the responsibilities of those departments with whom biostatisticians and statistical programmers interact.</span≥</li≥</ul≥<ul≥<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≥</ul≥<ul≥<li style="color: #000000;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥A substantial knowledge of the overall clinical trial process and of its application within Covance Clinical Development.</span≥</li≥<li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥A broad up-to-date knowledge of statistics as applied in clinical trials across therapeutic areas.</span≥</li≥<li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 12pt;"≥<span style="font-family: 'Arial',sans-serif; font-size: 12pt;"≥Demonstrates good knowledge of clinical research guidance, including Food and Drug Administration (FDA), international regulatory agencies, international conference on harmonization (ICH), and good clinical practice (GCP).</span≥</li≥</ul≥

Job posted: 2021-02-01

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