Industria Farmaceutica ofertas em United States

We have recently partnered with an award-winning CRO, who are looking for an experienced Principal Statistician (or Senior looking to move into Principal), to join their successful study delivery team, any area of specialism considered.

As a Principal Biostatistician, you will be accountable for:

• Leading Biostatistics and Programming activities for a program of studies with moderate complexity and/or high value and impact for the organization.
• Planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on the assigned program of studies.
• Ensuring the timely, budget-compliant delivery of individual studies and integrated analyses to the required quality standards.
• Maintaining consistency across studies within the program.
• Providing strategic oversight and direction, with a focus on optimal resource allocation and effective team performance.
• Leveraging your regulatory interaction experience to ensure compliance with regulatory standards and contribute to submissions and responses to regulatory inquiries.

• Providing biostatistical input into the design of clinical programs, including protocol input such as study design, sample size calculations, and patient randomization schemes.
• Contributing to statistical aspects of case report form (CRF) design.
• Reviewing project database structures, edit checks, and data management coding conventions.
• Preparing statistical analysis plans (SAP), defining derived data, and designing statistical tables, figures, and data listings for clinical summary reports.
• Conducting statistical analysis, interpreting data, and reporting results.
• Writing and reviewing statistical methods sections of integrated study reports.
• Supporting responses to regulatory questions on program design, labeling claims, and regulatory submissions.
• Participating in presentations at client and investigator meetings.
• Preparing biostatistics input for research proposals, defending proposals, and presenting at marketing meetings with prospective clients.

• M.S. or Ph.D. degree in statistics, biostatistics, or a related field.
• Strong experience in biostatistics or a related field, particularly in clinical trials and statistical analysis.
• Proven track record of leading Biostatistics and Programming activities for complex, high-value programs.
• Excellent leadership, coaching, and mentorship skills.
• In-depth knowledge of clinical trials methodology, regulatory requirements, and statistical software packages (e.g., SAS).
• Strong communication and collaboration skills, with the ability to present complex data and analysis to diverse stakeholders.

Ongoing development is vital, and as a Principal Biostatistician you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. In comparison with their competitors and pharmaceutical companies, they provide more flexible working platforms for coaching and educating newcomers to be highly respected professionals in our industry.

They also provide successful candidates with an excellent employment package and benefits adapted to the current job market. The company likes to look at themselves more like an extended family with consideration of staff as individuals allowing a work-life balance.

This is a company where their people set them apart. Diverse teams enable them to become a better partner to their customers and help to fulfill our mission to advance and improve patients’ lives.

The company has an ‘Own It’ culture, driven by four key values that bring them together as individuals and set them apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. It is key to be a CRO that delivers excellence to their clients and to patients at every touchpoint. In short, to be the partner of choice in drug development.

If this opportunity is of interest, please apply now with your CV as the organization is looking to welcome the new Statistician onboard as soon as possible.