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Senior / Principal Statistical Programmer - Submissions
hace 1 mes
Senior or Principal Biostatistician – Leading CRO – Homebased – Spain
Overview: We have recently partnered with an award-winning Contract Research Organization (CRO) who are seeking a highly experienced Senior or Principal Biostatistician to join their successful study delivery team. The ideal candidate will be responsible for leading biostatistics and programming activities for complex, high-value programs.
Key Responsibilities:
- Leading biostatistics and programming activities for complex, high-value programs.
- Planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on assigned programs.
- Ensuring timely, budget-compliant delivery of individual studies and integrated analyses to required quality standards.
- Maintaining consistency across studies within the program.
- Providing strategic oversight and direction, focusing on optimal resource allocation and effective team performance.
- Leveraging regulatory interaction experience to ensure compliance with regulatory standards and contribute to submissions and responses to regulatory inquiries.
Desirable Experience:
- Providing biostatistical input into clinical program design, 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.
Key Qualifications and Skills:
- 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.
What You Get in Return:
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. Our company provides flexible working platforms for coaching and educating newcomers to be highly respected professionals in our industry. Successful candidates also receive an excellent employment package and benefits adapted to the current job market.
Company Culture:
Our company values diversity, which enables us to become a better partner to our customers and help fulfill our mission to advance and improve patients' lives. We have an 'Own It' culture, driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity.
If this opportunity is of interest, please apply now with your CV as we are looking to welcome the new Statistician onboard as soon as possible.
