Principal Biostatistician, Single Sponsor, Home or Office-Based at Labcorp Drug Development

In this role you will develop and review Statistical Analysis Plans for data presentation, analyses, and provide programming support to your multidisciplinary global project team.

• This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas such as oncology, cardiovascular, respiratory, neurological, diabetes, rare diseases, pain, immunology etc. Your expertise and your work as a Biostatistician has a direct impact on improving the health and lives of thousands of patients around the globe every day. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers!

What else can you expect from us?

• Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
• Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
• A genuine work life balance
• Flexibility in working hours
• A thorough onboarding with support from your personal mentor
• A permanent employment contract with Labcorp Drug Development
• Excellent training and career development opportunities, as well as support with advancing your individual education
• Strong support from your Labcorp Line Manager and your team, as well as from more than 20,000 colleagues worldwide

Your Responsibilities

• Lead complex studies such as New Drug Applications submissions 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
• Serve as Data Monitoring Committee Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants
• Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
• Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery
• Review Case Report Form and other study specific specifications and plans
• Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
• 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
• Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
• Represent the department during audits.

Your Profile

• Degree in a relevant field such as statistics, computer sciences, etc.
• Solid experience of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company
• 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
• Proven professional experience with SDTMs, ADaM datasets and TFLs
• Proven ability to effectively communicate statistical concepts
• A good knowledge of the overall clinical trial process
• Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials
• Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail
• Business fluency in English – both verbal and written – is a must