We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.
Proclinical is seeking a Senior Lead of Statistical Programming with a focus on Oncology. This role involves developing strategies to enhance statistical analysis and reporting, managing programming teams, and ensuring compliance with regulatory standards. The position requires collaboration with various departments to support clinical study designs and global regulatory submissions.
Responsibilities:
- Collaborate with the Head of Statistical Programming to implement efficient strategies for statistical analysis and reporting.
- Oversee programming teams to ensure timely and high-quality delivery of analysis datasets and reports.
- Align programming strategies with regulatory requirements and project objectives.
- Drive the creation and validation of SAS/R programs for clinical data analysis.
- Ensure adherence to SOPs and regulatory standards.
- Partner with Biostatistics, Clinical Development, and other departments to shape study designs and submission strategies.
- Represent programming in key meetings and lead contributions to global regulatory submissions.
- Manage the production of submission-ready datasets and documentation.
- Champion the adoption of advanced analytics and new technologies to enhance efficiency.
- Develop standardized processes and mentor teams on industry trends.
- Participate in continuous improvement activities to enhance clinical operations and data analysis.
Key Skills and Requirements:
- Bachelor's degree in Statistics, Mathematics, Computer Science, or related discipline; advanced degree preferred.
- Extensive experience in the pharmaceutical industry or clinical research setting, focusing on oncology.
- Proficient in statistical programming using SAS.
- Strong understanding of FDA, EMA, ICH regulations, and CDISC standards.
- Knowledge of the drug development process and electronic submission requirements.
- Excellent interpersonal, written, and oral communication skills.
- Strong analytical, project management, and problem-solving skills.
- Ability to work in a fast-paced and dynamic environment.
If you are having difficulty in applying or if you have any questions, please contactHeidi Henniganat.
Apply Now:
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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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