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11+ years
$220,000 - $260,000 USD
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ Life Sciences/phd 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 TitleDirector, Biostatistics
LocationRemote - United States
Salary$220,000 - $260,000 USD
CompanyML Bio Solutions & BridgeBio Pharma

About ML Bio Solutions & BridgeBio Pharma

ML Bio Solutions, a BridgeBio company, is dedicated to developing groundbreaking treatments for Limb Girdle Muscular Dystrophy (LGMD2I/LGMDR9), with its drug BBP-418 potentially becoming the first oral treatment for this condition. BridgeBio Pharma is committed to delivering transformative medicines for genetic diseases and cancers, with a pipeline of 30+ drug development programs.

Responsibilities:

  • Lead Biostatistics Team: Oversee statistical and programming teams at the product level.
  • Study Design and Statistical Planning: Provide statistical input for study designs, including sample size calculation, protocol development, and results interpretation.
  • CRO/Vendor Oversight: Manage CRO biostatisticians and programmers, ensuring accurate and timely deliverables.
  • Health Authority Interaction: Contribute to documents for global Health Authorities and participate in meetings/teleconferences with them.
  • Collaboration: Work with cross-functional teams (e.g., Clinical Development, Regulatory, and Pharmacovigilance) to meet project goals.

Required Qualifications:

  • PhD in Biostatistics (or related field) and 8+ years of experience, or MS in Biostatistics with 11+ years of experience in the pharmaceutical/biotech industry.
  • Experience with NDA submissions.
  • Proficiency in SAS and/or R programming.
  • Strong knowledge of statistical methodologiesdrug development trends, and regulatory environments.
  • Ability to collaborate with cross-functional teams in a fast-paced environment.
  • Strong analytical and problem-solving skills.

What We Offer:

  • Patient Days, where you hear directly from patients and improve efforts to impact their conditions.
  • A culture inspired by values of patient-first, transparency, and excellence.
  • Flexible PTOmarket-competitive compensation, and career advancement opportunities.
  • decentralized model that empowers teams to focus on advancing science and helping patients.
  • Access to learning and development resources and a commitment to Diversity, Equity & Inclusion.

For more details, visit ML Bio Solutions and BridgeBio Pharma.