CSL Behring
Senior Biostatistician(m/w/x)
Vollzeitnur vor OrtSenior
Glattbrugg
Neuer Job?Nejo!
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CSCSL Vifor
Associate Director, Biostatistics(m/w/x)
Glattbrugg
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading biostatistics for innovative therapies in iron deficiency and nephrology, defining strategies for clinical trials and regulatory submissions. 8+ years drug development experience with statistical leadership at compound/indication level required. Global project scope in precision healthcare.
Anforderungen
- PhD or MS in Biostatistics, Statistics, or related field
- PhD with 8 years or MS with 11 years experience in drug development
- Statistical leadership experience at compound/indication level
- Statistical expertise and leadership in clinical development strategy
- Solid experience in advanced statistical methodologies
- Leading roles in regulatory submissions
- Experience in interactions with major regulatory authorities (preferred)
- Experience with CROs or managing internal deliveries (preferred)
- Track record of innovation (preferred)
- Familiarity with regulatory guidance and interactions
- Broad knowledge of clinical development and processes
- Collaborative work and leadership in matrix environment
- Strong interpersonal and communication skills (verbal and written in English)
- Good working knowledge of SAS and/or R
- Expertise in a range of statistical methodologies
- Innovative/creative methodology for clinical data analysis
- Familiarity with relevant regulatory guidance documents
- Expertise in
- CDISC, statistical programming, and/or data standards
Aufgaben
- Lead biostatistics for assigned therapeutic programs.
- Define statistical strategies for clinical trials.
- Define statistical strategies for regulatory submissions.
- Ensure appropriate statistical methodologies for study design and data analysis.
- Influence and contribute to clinical development plans.
- Collaborate with cross-functional teams on governance reviews.
- Lead statistical strategy for study planning and execution.
- Lead quantitative evaluations for clinical trials and regulatory submissions.
- Lead quantitative evaluations for related documents.
- Provide statistical thought partnership for innovative study design.
- Provide statistical thought partnership for clinical development plans.
- Develop Go-No Go criteria.
- Perform probability of technical success calculations.
- Plan analyses across all projects.
- Ensure quality and timely delivery of interim results.
- Ensure quality and timely delivery of final results.
- Deliver integrated analyses for submissions.
- Represent Biostatistics to regulatory authorities.
- Interpret analysis results.
- Ensure reporting accuracy in study reports.
- Ensure reporting accuracy in regulatory documents.
- Manage biostatistics outsourcing operations.
- Collaborate with internal statistical programmers.
- Ensure timeliness of CRO/FSP deliverables.
- Ensure quality of CRO/FSP deliverables.
- Support improvement initiatives across the organization.
- Lead improvement initiatives across the organization.
- Prepare abstracts, posters, and oral presentations.
- Prepare written reports on clinical programs and studies.
- Communicate clinical results to diverse stakeholders.
Berufserfahrung
- 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- R
- CDISC
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Vifor 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.
Noch nicht perfekt?
- CSL Plasma
Principal Biostatistician(m/w/x)
Vollzeitnur vor OrtSeniorSchlieren - CSL Behring
Associate Director, Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - CSL Behring
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Vollzeitnur vor OrtSeniorSchlieren - CSL Behring
Senior Director Global Clinical Program Lead Cardiovascular & Renal(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg
CSCSL Vifor
Associate Director, Biostatistics(m/w/x)
Glattbrugg
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading biostatistics for innovative therapies in iron deficiency and nephrology, defining strategies for clinical trials and regulatory submissions. 8+ years drug development experience with statistical leadership at compound/indication level required. Global project scope in precision healthcare.
Anforderungen
- PhD or MS in Biostatistics, Statistics, or related field
- PhD with 8 years or MS with 11 years experience in drug development
- Statistical leadership experience at compound/indication level
- Statistical expertise and leadership in clinical development strategy
- Solid experience in advanced statistical methodologies
- Leading roles in regulatory submissions
- Experience in interactions with major regulatory authorities (preferred)
- Experience with CROs or managing internal deliveries (preferred)
- Track record of innovation (preferred)
- Familiarity with regulatory guidance and interactions
- Broad knowledge of clinical development and processes
- Collaborative work and leadership in matrix environment
- Strong interpersonal and communication skills (verbal and written in English)
- Good working knowledge of SAS and/or R
- Expertise in a range of statistical methodologies
- Innovative/creative methodology for clinical data analysis
- Familiarity with relevant regulatory guidance documents
- Expertise in
- CDISC, statistical programming, and/or data standards
Aufgaben
- Lead biostatistics for assigned therapeutic programs.
- Define statistical strategies for clinical trials.
- Define statistical strategies for regulatory submissions.
- Ensure appropriate statistical methodologies for study design and data analysis.
- Influence and contribute to clinical development plans.
- Collaborate with cross-functional teams on governance reviews.
- Lead statistical strategy for study planning and execution.
- Lead quantitative evaluations for clinical trials and regulatory submissions.
- Lead quantitative evaluations for related documents.
- Provide statistical thought partnership for innovative study design.
- Provide statistical thought partnership for clinical development plans.
- Develop Go-No Go criteria.
- Perform probability of technical success calculations.
- Plan analyses across all projects.
- Ensure quality and timely delivery of interim results.
- Ensure quality and timely delivery of final results.
- Deliver integrated analyses for submissions.
- Represent Biostatistics to regulatory authorities.
- Interpret analysis results.
- Ensure reporting accuracy in study reports.
- Ensure reporting accuracy in regulatory documents.
- Manage biostatistics outsourcing operations.
- Collaborate with internal statistical programmers.
- Ensure timeliness of CRO/FSP deliverables.
- Ensure quality of CRO/FSP deliverables.
- Support improvement initiatives across the organization.
- Lead improvement initiatives across the organization.
- Prepare abstracts, posters, and oral presentations.
- Prepare written reports on clinical programs and studies.
- Communicate clinical results to diverse stakeholders.
Berufserfahrung
- 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- R
- CDISC
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Vifor 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.
Über das Unternehmen
CSL Vifor
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Partner für pharmazeutische Produkte und innovative Therapien in der Eisenmangel- und Nephrologie.
Noch nicht perfekt?
- CSL Behring
Senior Biostatistician(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - CSL Plasma
Principal Biostatistician(m/w/x)
Vollzeitnur vor OrtSeniorSchlieren - CSL Behring
Associate Director, Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg - CSL Behring
Associate Director, Hematology(m/w/x)
Vollzeitnur vor OrtSeniorSchlieren - CSL Behring
Senior Director Global Clinical Program Lead Cardiovascular & Renal(m/w/x)
Vollzeitnur vor OrtSeniorGlattbrugg