Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook
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.