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Sumitomo Pharma America, Inc.

We are united in our mission to deliver patient-needed therapies sooner.

Associate Director, Biostatistics

DirectorDirectorFull TimeRemoteSeniorTeam 1,001-5,000H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

18 days ago

Salary

$165.8K - $207.2K / year

Seniority

Senior

Postgraduate Degree5 yrs expEnglish

Job Description

Associate Director, Biostatistics

Sumitomo Pharma America, Inc.

• Serve as the biostatistics lead for one or more studies within a project team, offering expertise in study design, operations, decision rules, and analysis planning. • Author and oversee the production of statistical sections of protocols and analysis plans, and contribute to the statistical sections of publications across multiple clinical projects. • Provide coaching and management for junior biostatisticians, fostering their professional development and ensuring high-quality output. • Plan, manage, and supervise the statistical activities conducted by Contract Research Organizations (CROs) to ensure alignment with project objectives and standards. • Offer guidance to junior statisticians and statistical programmers on developing SDTM/ADaM datasets and TLFs (Tables, Listings, and Figures) specifications, as well as perform quality checks on statistical programming efforts as needed.

Job Requirements

  • PhD or MS in statistics or biostatistics. PhD is preferred.
  • Minimum 5-year (for PhD) or 8-year (for MS) experience in clinical trials is required
  • Broad and thorough understanding of statistical principles, up-to-date statistical design and methodologies, and their applications into clinical trial
  • Strong statistical leadership in a multi-functional project environment: able to manage many projects simultaneously as well as conflicting priorities
  • Effective writing and communication skills: able to author various statistical documents; able to explain to team clearly and help team understand complex statistical design, methodology, decision rule, analysis plan and statistical report
  • Experience with Bayesian modeling and Analysis
  • Experienced with SAS programming, R programming and other statistical software
  • Experience with AI or agentic AI in statistical reporting is a plus
  • People management is a plus

Benefits

  • merit-based salary increases
  • short incentive plan participation
  • eligibility for our 401(k) plan
  • medical, dental, vision, life and disability insurances
  • flexible paid time off
  • 11 paid holidays plus additional time off for a shut-down period during the last week of December
  • 80 hours of paid sick time upon hire and each year thereafter

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