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Associate Director, Biostatistics Remote - United States

8+ years
$185,000 - $235,000 USD
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: Ph.D. or MS 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 TitleAssociate Director, Biostatistics
LocationRemote - United States
Salary$185,000 - $235,000 USD
CompanyQED Therapeutics & BridgeBio Pharma

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, a BridgeBio Pharma affiliate, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia, a condition causing genetic short stature with medical complications. BridgeBio, founded in 2015, bridges genetic science advancements to create transformative medicines for genetic diseases and cancers.

Responsibilities:

  • Study Design: Provide statistical input for study design, protocol development, sample size calculation, and clinical study reports.
  • Collaboration: Work with CROs, biostatisticians, clinical development, operations, and regulatory teams to meet timelines and deliverables.
  • Vendor Oversight: Manage CRO biostatisticians and statistical programmers, ensuring accurate deliverables on time.
  • Global Health Authority Interaction: Contribute to Health Authority submissions and participate in meetings with global regulatory bodies.
  • Safety Analyses: Support statistical analyses for safety updates and ad hoc reports.

Required Qualifications:

  • Ph.D. or MS in Biostatistics/Statistics with 5+ years (Ph.D.) or 8+ years (MS) of relevant experience in the pharmaceutical/biotech industry.
  • Proven expertise in applying statistics to clinical trials.
  • Experience with SAS and/or R programming, CDISC standards (SDTM, ADaM), and ICH guidelines.
  • Familiarity with FDA and other regulatory authorities' guidance.
  • Strong leadership, communication, and interpersonal skills.

Preferred Qualifications:

  • NDA experience, including eCTD submission.

What We Offer:

  • Competitive salary and benefits package (Base, Bonus, Equity, Health, Welfare, and Retirement programs).
  • Flexible PTO and market-competitive compensation.
  • Opportunity to work across multiple therapeutic areas over time.
  • Career advancement and learning development resources.
  • patient-first culture, with a commitment to Diversity, Equity & Inclusion.

BridgeBio Pharma values independence, radical transparency, and collaboration, offering a dynamic, data-driven work environment.

To learn more about our mission and values, visit QED Therapeutics and BridgeBio Pharma.

 

 

 

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