Associate Director of Biostatistics

in Pharma Permanent

Job Detail

  • Experience Level Manager
  • Degree Type Doctor of Philosophy (PhD)
  • Employment Full Time
  • Working Type Remote
  • Job Reference 0000009064
  • Salary Type Annually
  • Industry Pharmaceuticals
  • Selling Points

    Seeking a remote Associate Director of Biostatistics to lead statistical activities for clinical trials at an innovative biotech company.

Job Description

Key Responsibilities:

  • Represent biostatistics in cross-functional team meetings to drive clinical development strategies.
  • Collaborate with Clinical Development, Regulatory, and Clinical Operations teams to design clinical trials.
  • Author statistical sections of clinical trial protocols in consultation with internal and external experts.
  • Prepare or contribute to statistical analysis plans.
  • Work with Data Management and Clinical Operations to design eCRFs.
  • Provide statistical guidance on the execution of ongoing trials.
  • Partner with Statistical Programmers on data summaries and analyses.
  • Write specifications for analysis datasets (ADS) and ad hoc analyses.
  • Contribute to clinical study reports and other regulatory documents, such as DSURs and briefing documents.
  • Engage with regulatory authorities, Key Opinion Leaders, partners, and other stakeholders.
  • Contribute to scientific publications summarizing clinical trial data.
  • Participate in Biostatistics and Development Team activities and meetings.
  • Provide statistical consultation to Research and Preclinical teams.
  • Manage CRO statistical and programming support.

Qualifications:

  • Ph.D. in Biostatistics, Statistics, or a related field with 7+ years of pharmaceutical biostatistics experience, or MS with 10+ years of relevant experience.
  • Strong written and verbal communication and presentation skills.
  • Proficiency in SAS programming.
  • Basic understanding and interest in biology and biological processes.

Preferred Experience:

  • Clinical development experience through Phase 3, including NDA submissions.
  • Experience as a lead statistician for a compound.
  • Familiarity with ICH GCP and industry standards.
  • Proficiency in R and other statistical software (e.g., EAST).
  • Knowledge of CDISC standards, including SDTM, ADaM, and CDASH.
  • Experience with adaptive trial designs.
  • Representation of sponsors in regulatory interactions with the FDA and international authorities.
  • ShareAustin:

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