Biostatistics Director RWE

As an experienced Director Biostatistician in our Consulting business supporting our Real-World Evidence (RWE) service, you are central to the successful delivery of complex RWE studies for renowned, innovative and global top pharmaceutical and biotech companies. You will have the opportunity to lead RWE studies and support post-market regulatory submissions and publications.

In this role you will develop and review Statistical Analysis Plans (SAPs) for data presentation, analyses, and provide SAS programming oversight.

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 Fortrea
• Excellent training and career development opportunities, as well as support with advancing your individual education
• Strong support from your Fortrea Line Manager and your team, as well as from more than 19,000 colleagues worldwide

Your responsibilities:

• Lead complex studies 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
• Lead the development of complex SAPs perform senior review of SAPs developed by other statisticians
• Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery
• Work with data management to implement and review Case Report Forms and other study specific specifications and plans to align with observational study data collection
• Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
• 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 team meetings and at external scientific meetings and conferences
• Attend bid defense meetings
• Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives

Your profile:

• Advance degree in a relevant field such as biostatistics, computer sciences, etc. (Doctoral degree preferred)
• 10 or more years of 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 observational study process
• Competence in the preparation of SAPs, analysis, and reporting
• 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

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

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