Principal Biostatistician, single sponsor, home or office-based EMEA

Employer
Labcorp Drug Development - USA
Location
Lithia Springs, Georgia, United States; Homeworking
Salary
Competitive
Start date
8 Jan 2023
Closing date
7 Feb 2023

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

As an experienced Principal Biostatistician in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials for renowned, innovative and global top pharmaceutical and biotech companies. You will have the opportunity to lead studies through various phases of the clinical development plan and support submissions, regulatory questions, publications as well as ad hoc and post hoc requests.

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


Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement .

Company

Labcorp Drug Development, a leading contract research organization (CRO), is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Together with our clients, we support the development of innovative, life-changing treatments. We look to the future and work tirelessly to test new drugs, treatments and therapies. Labcorp supports clinical trial activity in approximately 100 countries, generating more safety and efficacy data to support drug approvals than any other company.

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