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eClinical Solutions

We bring people and data together to support tomorrow’s breakthroughs

Principal Biostatistician

Clinical ResearchClinical ResearchOtherRemoteLeadTeam 201-500Since 2012H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

114 days ago

Salary

$160K - $220K / year

Seniority

Lead

Postgraduate Degree5 yrs expEnglishGCP

Job Description

Principal Biostatistician

eClinical Solutions

• Provide consulting of statistics activities related to clinical trials • Fulfill the responsibilities of study statistician as required • Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications • Act as study statistician - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel • Develop, review, and finalize the statistical analysis plan • Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis • Develop randomization schedule, specifications, and guidelines • Where applicable, provide input in finalization of study specific data quality control plan • Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately • Analyze the data and contribute to trial progression related decisions • Collaborate with team members for regulatory reviews, representations, and supporting data analyses

Job Requirements

  • Master in Statistics, Biostatistics, or equivalent work experience preferred
  • Excellent knowledge of English
  • SAS® certification is preferred
  • 5+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred
  • Strong experience with clinical study design development, analysis, and sample size determination
  • Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA
  • Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables
  • Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
  • Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial
  • Ability and experience of delegating tasks and leading projects

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development
  • Wellness programs

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THE ANTI-TROLL

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