Job Vacancies at Labcorp Drug Development

Description

• Senior Biostatistician required to work for Labcorp Drug Development in a Lead role
• Working with multiple Sponsors across several therapeutic areas in all phases of clinical trials
• This is a permanent full-time role, either office based or home based anywhere in Europe or in South Africa
• You must have some previous experience of Leading studies as a Biostatistician in either a biotech, CRO or pharma company

Job Primary Functions

• Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings
• Perform project management activities for identified projects including resource planning, timelines and milestone management
• Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff
• 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
• May perform sample size calculation for simple studies under the supervision of more senior statistical staff
• Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant
• Provide statistical input and review of the CSR for medium complexity studies
• Preparation and review of randomization specifications and generation of randomization schedules
• Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department
• Present and share knowledge at team meetings and/or at monthly seminars
• Attend bid defense meetings for medium complexity studies in order to win new business
• Represent the department during project-driven client audits.

Job Qualifications

• Master’s degree, equivalent, or higher in Biostatistics or related field
• You must have some previous experience of Leading studies as a Biostatistician in either a biotech, CRO or pharma 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
• 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
• You must be fluent in English language (both verbal and written)

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Description

• Biostatistician 2 required to work for Labcorp Drug Development supporting the Lead Biostatistician
• Opportunity to develop into a Lead Biostatistician and beyond
• Working with multiple Sponsors across several therapeutic areas in all phases of clinical trials
• This is a permanent full-time role, either office based or home based anywhere in Europe or in South Africa
• You must have some previous experience of working as a Biostatistician within clinical trials

Job Primary Functions

• Perform Lead Biostatistician role on simple studies, providing statistical oversight and attending relevant project meetings
• Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate
• Preparation of Statistical Analysis Plans (including mock TFL shells) for simple and medium complexity studies under the supervision of senior statistical staff
• Perform statistical analysis for medium complexity studies
• Conduct overall statistical review of TFLs for medium complexity studies prior to client delivery
• Review CRF and other study specific specifications and plans
• May perform sample size calculation for Clinical Pharmacology studies under the supervision of senior statistical staff
• Provide statistical input and review of the CSR for simple studies
• Generation and review of randomization schedules from provided specifications under the supervision of senior statistical staff

Job Qualifications

• Master’s degree, equivalent, or higher in Biostatistics or related field
• Ability to program in one or more statistical software packages (SAS® preferred) used to conduct statistical analyses
• Ability to effectively communicate statistical concepts
• Interpersonal and effective communication skills
• Cooperative and team-oriented
• Self-motivation
• The ability to work to tight deadlines while maintaining high standards
• You must be fluent in English language (both verbal and written)

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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