• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Dir./Sr. Dir. Biostatistics.

Job Number: 35307

Location:

Job Description

In this role, reporting to the VP of Biometrics, you will work with cross-functional clinical teams, overseeing statistical activities and managing outsourced deliverables. This position offers the chance to impact the development of transformative therapies. Strong communication, collaboration, and self-motivation are key.

Responsibilities

  • Serve as a biostatistics expert for clinical programs.
  • Provide strategic input on trial designs for early and late-phase studies.
  • Collaborate with internal and CRO teams on statistical deliverables.
  • Conduct statistical modeling to optimize designs and address issues.
  • Contribute to clinical protocol development and statistical analysis plans.
  • Oversee development of tables, figures, and listings for trials.
  • Ensure eCRF designs meet analysis requirements.
  • Support regulatory submissions and address agency questions.
  • Contribute to publications and represent the company externally.
  • Lead process improvement for Biostatistics.
  • Support inspection readiness and maintain advanced statistical skills.
  • Perform additional duties as needed.

Required Skills

  • PhD in statistics or related field; or MS with relevant experience
  • 8+ years in the pharmaceutical or biotech industry
  • Experience in clinical trial design, analysis, and reporting
  • Familiarity with INDs, NDAs, MAAs, or regulatory submissions
  • Strong knowledge of clinical trial statistical methods and regulations
  • Proficient in SAS and R programming
  • Ability to lead statistical efforts across multiple studies
  • Knowledge of data standards like SDTM and ADaM
  • Experience with outsourced CRO statistical services
  • Independent, proactive problem solver
  • Strong written and oral communication skills, especially in conveying statistical concepts

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