Senior Manager – Biostatistics

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🕒 vor 2 Monaten

🏄 California – Remote

🏄 California – Remote

💵 $145.000 - $175.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Direktor

Jetzt Bewerben

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Codera

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11 - 50 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

🤝 B2B

Biotechnology • Pharmaceuticals • B2B

Codera ist ein B2B-Unternehmen, das mit Biotechnologie- und Pharmaunternehmen zusammenarbeitet, um umfassende Fachkenntnisse und Infrastruktur für die Arzneimittelentwicklung bereitzustellen. Es unterstützt Kunden im gesamten Lebenszyklus der Arzneimittelentwicklung mit technischen, betrieblichen und infrastrukturellen Dienstleistungen, um therapeutische Programme voranzutreiben.

Beschreibung

• Provide statistical expertise and input to clinical development programs • Author detailed statistical analysis plans including the evaluation of study objectives/endpoints, the structure and content of analysis datasets, derivation of variables and sample size/power calculation • Plan the contents and format of tables, listings and figures (TLFs) to be programmed for the clinical study report (CSR) • Review CDISC datasets and associated documentation/metadata • Review Data Management associated documentation and setup of databases • Support the generation of posters and publications • Develop statistical programs for data review including detailed listings to identify data issues and vendor reconciliation • Conduct statistical programming as needed to support quality control of analyses and the success of clinical development programs • Review and provide input on project related clinical documents from a statistical perspective including protocols, development safety update reports, investigator brochures, and CSRs • Assist with development of SOPs and quality procedures for biostatistics

🎯 Anforderungen

• Master’s Degree in Biostatistics required • PhD Degree preferred • Minimum 4-6 years of biostatistics experience working in the pharmaceutical industry required • Must be proficient in SAS with an understanding of CDISC datasets standards • Familiarity with Phoenix WinNonlin for non-compartmental analyses preferred • Advanced and broad knowledge of statistical methods and an understanding of pharmaceutical industry practices • Must be self-motivated, well-organized, detail-oriented and have excellent written and verbal communication skills • Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines • Ability to establish and maintain collaborative working relationships with internal and external stakeholders.