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Principal Biostatistician(m/w/x)
Leading statistical strategy for Clinical Trial Teams (CTT) at a global clinical research provider. Independent study statistician experience in late-phase clinical trials, pharmaceutical industry experience strongly preferred. Diverse global clinical trial projects.
Anforderungen
- Advanced degree in Biostatistics, Statistics, or related field (PhD preferred; Master’s with significant experience)
- Proven independent study statistician experience in late-phase clinical trials
- Pharmaceutical industry experience (strongly preferred); CRO experience (plus)
- Hands-on expertise with clinical outcomes studies
- Ability to implement complex statistical methods and guide analytical decision-making
- Proficiency in SAS; working knowledge of R (advantageous)
- Regulatory submissions and health authority interaction experience (plus)
Aufgaben
- Lead as the primary statistician on the CTT.
- Represent Biostatistics on the CTT.
- Work independently to support clinical teams.
- Provide proactive statistical guidance.
- Lead statistical strategy discussions.
- Define study endpoints and analysis methods.
- Address risk mitigation and regulatory expectations.
- Independently author Statistical Analysis Plans (SAPs).
- Conduct complex time-to-event analyses.
- Apply MMRM and longitudinal models.
- Utilize estimand-aligned statistical methods.
- Perform and oversee statistical analyses.
- Conduct sample size calculations using SAS or R.
- Justify design assumptions to clinical leadership.
- Collaborate with statistical programmers.
- Provide clear direction to programmers.
- Review statistical programming outputs.
- Ensure SAP and programming alignment.
- Perform hands-on SAS programming for clinical datasets.
- Actively participate in CTT meetings.
- Drive alignment across cross-functional teams.
- Communicate proactively with team members.
- Anticipate team needs and address issues.
- Ensure clarity on statistical approaches.
- Explain statistical concepts to non-statistical stakeholders.
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- R
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Principal Biostatistician(m/w/x)
Leading statistical strategy for Clinical Trial Teams (CTT) at a global clinical research provider. Independent study statistician experience in late-phase clinical trials, pharmaceutical industry experience strongly preferred. Diverse global clinical trial projects.
Anforderungen
- Advanced degree in Biostatistics, Statistics, or related field (PhD preferred; Master’s with significant experience)
- Proven independent study statistician experience in late-phase clinical trials
- Pharmaceutical industry experience (strongly preferred); CRO experience (plus)
- Hands-on expertise with clinical outcomes studies
- Ability to implement complex statistical methods and guide analytical decision-making
- Proficiency in SAS; working knowledge of R (advantageous)
- Regulatory submissions and health authority interaction experience (plus)
Aufgaben
- Lead as the primary statistician on the CTT.
- Represent Biostatistics on the CTT.
- Work independently to support clinical teams.
- Provide proactive statistical guidance.
- Lead statistical strategy discussions.
- Define study endpoints and analysis methods.
- Address risk mitigation and regulatory expectations.
- Independently author Statistical Analysis Plans (SAPs).
- Conduct complex time-to-event analyses.
- Apply MMRM and longitudinal models.
- Utilize estimand-aligned statistical methods.
- Perform and oversee statistical analyses.
- Conduct sample size calculations using SAS or R.
- Justify design assumptions to clinical leadership.
- Collaborate with statistical programmers.
- Provide clear direction to programmers.
- Review statistical programming outputs.
- Ensure SAP and programming alignment.
- Perform hands-on SAS programming for clinical datasets.
- Actively participate in CTT meetings.
- Drive alignment across cross-functional teams.
- Communicate proactively with team members.
- Anticipate team needs and address issues.
- Ensure clarity on statistical approaches.
- Explain statistical concepts to non-statistical stakeholders.
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
- R
Über das Unternehmen
IQVIA
Branche
Healthcare
Beschreibung
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
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