Therapeutics Inc. logo
Therapeutics Inc.

The only full-service dermatology CRO that takes products from concept to approval.

Senior Biostatistician

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

California

Posted

83 days ago

Salary

$115K - $140K / year

Seniority

Senior

Postgraduate Degree5 yrs expEnglish

Job Description

Senior Biostatistician

Therapeutics Inc.

• Leadership and Project Management of statistical aspects of assigned project portfolio • Oversight and development of statistical and programming techniques to ensure quality and on time delivery of generated results • Contribute to the writing of statistical sections of study protocols • Perform sample size calculation, develop randomization specifications • Review and provide statistical input into the development of case report forms design • Author Statistical Analysis Plans (SAPs) • Research, development and application of statistical methodologies and processes • Develop and/or review SDTM and ADaM dataset specifications • Create table and listing shells per the SAP • Generate database listings for QA audits • Assist data management and trial management team in preparing for database lock • Write and/or supervise SAS programming and QC to create SDTM and ADaM data sets • Perform statistical analyses of data and interpret results • Collaborate with medical writer in the production of integrated clinical study reports • Contribute to the regulatory submissions including development of Integrated Summaries of Safety (ISS) and Efficacy (ISE) • Interact with members of the Clinical Development Team • Participate in Clinical Development Team meetings and client meetings • Participate in departmental infrastructure building and maintain programming standards.

Job Requirements

  • Master’s or Doctoral level degree in statistics
  • At least 5 years of experience performing statistical analysis and reporting for clinical trials
  • Thorough understanding of GCPs, FDA and ICH guidelines
  • Excellent problem solving, organizational, written and oral communication skills
  • Ability to manage multiple priorities and attention to detail
  • Strong computer proficiency and SAS programming skills
  • Knowledge of core technical and regulatory requirements
  • Sound experience in the design, analysis and reporting of clinical studies
  • Strong communication, collaboration and team working skills.

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