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Codera, LLC · 15 hours ago

Senior Manager, Biostatistics

United States

Full-time

Remote

Mid, Senior Level

4+ years exp

Codera, LLC is a life-sciences focused investment company that provides in-house end-to-end drug development capabilities for its portfolio companies. The Senior Manager, Biostatistics will oversee the design and quality control of clinical data processes, provide statistical input for study designs, and ensure the validity and quality of statistical deliverables for clinical studies.

Biotechnology

No H1B

Responsibilities

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

Qualification

BiostatisticsSASCDISC standardsStatistical methodsPhoenix WinNonlinOrganizedWritten communicationVerbal communicationDetail-orientedSelf-motivated

Required

Master's Degree in Biostatistics required

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

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