BioNTech SE
(Senior-) Director, Clinical Development(m/w/x)
Vollzeit
mit Homeoffice
Keine Angabe
Mainz, München
CL
ClinChoice29 Tage
Director Statistical Programming(m/w/x)
Vollzeit
Remote
Senior
AI/ML Job
Keine Angabe
Mainz
Nejo KI-Zusammenfassung
In this role, you will lead a team to enhance statistical programming efficiency, ensuring high-quality data analysis and compliance with regulatory standards while collaborating with various departments to meet project timelines.
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Anforderungen
- •Bachelor’s degree in Statistics, Mathematics, Computer Science, or related discipline
- •15+ years experience in pharmaceutical industry, CRO, or clinical research setting with focus on oncology
- •Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
- •Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
- •Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
- •Solid understanding of the drug development process from early to late-stage development and submission
- •Expertise in the requirements and technology to support electronic submissions
- •Strong interpersonal skills and exceptional written and oral communication skills
- •Strong analytical, project management, and problem-solving skills
- •Ability to work in a fast-paced and dynamic environment
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
15 Jahre
Deine Aufgaben
- •Implement strategies to maximize efficiency in statistical analysis and reporting
- •Oversee a team of FSP programmers and vendor CROs for timely delivery of analysis datasets
- •Align programming strategies with regulatory requirements and compound objectives
- •Drive the creation and validation of SAS/R programs for clinical data analysis
- •Ensure adherence to SOPs and regulatory standards
- •Collaborate with Biostatistics and Clinical Development on study designs and analysis plans
- •Represent programming in clinical study team meetings and protocol reviews
- •Lead programming contributions to global regulatory submissions
- •Manage production of submission-ready datasets and documentation
- •Champion the adoption of advanced analytics and automation tools
- •Develop standardized processes and mentor teams on industry trends
- •Establish efficient processes and innovative solutions for statistical reporting
- •Participate in continuous improvement activities for clinical operations
Tools & Technologien
SAS
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens ClinChoice erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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