Qodra | Intelligent solutions. Real-world impact
Senior Manager – Biostatistics
Location
California
Posted
83 days ago
Salary
$145K - $175K / year
Seniority
Senior
Job Description
Senior Manager – Biostatistics
Codera
• 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
Job Requirements
- 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.
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