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Associate Director, Biostatistics

5+ years
$185,000 - $235,000 USD
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: Ph.D./M.S 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, an affiliate of BridgeBio Pharma, specializes in developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. BridgeBio's mission is to bridge advancements in genetic science with the delivery of transformative medicines for genetic diseases and cancers.

Responsibilities:

  • Statistical Leadership: Provide statistical input for study design, protocol development, and sample size calculations.
  • Collaborate Across Teams: Work with cross-functional teams such as Clinical Development, Clinical Operations, Regulatory, and Data Managers to meet project timelines and deliverables.
  • CRO & Vendor Oversight: Guide CRO biostatisticians and statistical programmers, ensuring accurate deliverables according to timelines.
  • Health Authority Interaction: Contribute to documents submitted to global Health Authorities and potentially participate in meetings.
  • Statistical Analysis & Reporting: Coordinate the preparation of statistical analyses for various reports and updates, including IB and DSUR.

Required Qualifications:

  • Ph.D. in Biostatistics/Statistics with 5+ years of relevant experience, or MS in Biostatistics/Statistics with 8+ years of experience in the pharmaceutical/biotech industry.
  • Expertise in clinical trial statistics and proficiency in SAS or R programming.
  • Knowledge of CDISC standards (SDTM, ADaM) and regulatory guidelines (FDA, ICH).
  • Strong leadership and communication skills, capable of translating complex statistical concepts to non-experts.

What We Offer:

  • Competitive salary and market-competitive compensation (Base, Bonus, Equity, Health Benefits).
  • Flexible PTO and rapid career advancement opportunities.
  • collaborative, fast-paced, and data-driven environment.
  • Access to learning and development resources for professional growth.
  • Opportunity to work across multiple therapeutic areas and partnerships with leading institutions.

BridgeBio's decentralized structure encourages independence, ownership, and a commitment to patient-first values and scientific excellence.

For more details, visit QED Therapeutics and BridgeBio Pharma.