Labcorp Associate Director, Biostatistics in Durham, North Carolina
Hiring for Associate Director, Biostatistics (Remote) FSP: can be based anywhere in USA/ Canada #LI-REMOTE
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.
Perform project management activities for identified projects including resource planning, timelines and milestone management.
Attend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new business.
Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings
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.
Coordinate 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.
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.
Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives.
Advise on and coordinate biostatistical aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers.
Participates in internal and client audits, and regulatory inspections.
Proactively lead, review and amend departmental processes and documentation.
Establish and maintain client relationships and implement appropriate action plans based on client feedback.
- Master’s degree, equivalent, or higher in Biostatistics or related field
Minimum 12 + years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job.
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.
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.
Excellent problem solving skills, and a willingness to take ownership of decision-making.
Interpersonal and effective communication skills; able to communicate appropriately throughout Covance by Labcorp and with its clients.
A substantial knowledge of the overall clinical trial process and of its application within Covance by Labcorp Clinical Development.
Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials.
A broad up-to-date knowledge of statistics as applied in clinical trials across therapeutic areas.
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).