Senior Manager – Biostatistics
Codera
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $145,000 - $175,000 per year
Job Level
About the role
- 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
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysissample size calculationpower calculationstatistical programmingdata reviewCDISC standardsstatistical methodsnon-compartmental analysesSASbiostatistics
Soft Skills
self-motivatedwell-organizeddetail-orientedexcellent written communicationexcellent verbal communicationresults-driventime managementcollaborativestakeholder managementproblem-solving
Certifications
Master’s Degree in BiostatisticsPhD Degree