*Remote Position*

Senior Biostatistician

Job Description
A Senior Biostatistician is an expert in the design, management, technical oversight, and quality of statistical analyses and reporting of clinical trial data ensuring timelines and company strategic objectives are met.

Responsibilities
• Serves as a lead role on projects and a liaison between different internal functions and between internal and external teams
• Leads aspects of the statistical analysis including:
    o Contributes to the design of clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.
    o Contributes to the development of clinical trial protocols and clinical study reports; writes the statistical methodology section of these documents.
    o Prepares statistical analysis plans, statistical output shells.
    o Contributes to analysis dataset specifications.
    o Contributes to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
    o Contributes to the electronic submission of clinical trial data to regulatory authorities.
• Proactively solves problems of statistical complexity.
• Provides input or lead data standardization efforts (e.g., CRF and database design, edit checks, data standards such as CDISC SDTM/ADaM, and e-submissions).
• Participates effectively as a key member of clinical study teams.
• Provides analytical insight on statistical methodology and advice to internal teams accordingly.
• Keeps current with new clinical trial designs and statistical methodology.
• As necessary, provides work direction, guidance, mentoring, influence and support to junior staff. Trains junior staff in more complex statistical methodology. 

Qualifications
• Master’s degree or PhD in Statistics or Biostatistics.
• Master’s degree with 3-5 years or PhD with 0-2 years of experience in the Biotech or Pharmaceutical industry.
• CDISC STDM/ADaM experience.
• Sufficient knowledge of clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
• Proficient in SAS; familiar with sample size software such as nQuery or PASS.
• Experience as a Lead Biostatistician on several concurrent projects. 
• Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Please submit your application (resume, cover letter) to HR@DuBuResearch.com