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Senior/Director Biostatistics

10+ years
$230K/yr - $300K/yr
10 Nov. 14, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Director, Biostatistics or Director, Biostatistics

Location: Hybrid (3x weekly in San Diego, CA)

Job Overview:
We are seeking a skilled and experienced Senior Director of Biostatistics to lead and advance the biostatistics function for clinical development programs. This is an exciting opportunity for a strategic thinker who thrives in clinical research and is passionate about data-driven decision-making. The successful candidate will oversee statistical strategies, ensure regulatory compliance, and mentor a team of biostatisticians.

Key Responsibilities:

  • Lead the biostatistics function for clinical trials, ensuring the integrity and accuracy of statistical analyses.
  • Develop and implement statistical strategies, including study design, sample size calculations, and statistical analysis plans.
  • Collaborate with cross-functional teams, offering statistical insights throughout the clinical development process.
  • Mentor and manage a team of biostatisticians, fostering a collaborative and improvement-oriented culture.
  • Ensure compliance with regulatory standards and best practices in biostatistics.
  • Communicate complex statistical concepts to non-statistical stakeholders and present findings to senior leadership.

Qualifications:

  • PhD in Biostatistics, Statistics, or a related field (Master’s degree with significant experience will also be considered).
  • Minimum of 15 years of experience in biostatistics within the pharmaceutical or biotech industry, including at least 5 years in a leadership role.
  • Proven track record in managing complex clinical trials and statistical analyses.
  • Strong knowledge of regulatory requirements and biostatistics guidelines.
  • Excellent communication and leadership skills with the ability to collaborate effectively across teams.