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Asahi Kasei
Asahi Kasei
H1B Visa SponsorConstructionFood & BeverageHealthcare
Asahi Kasei is a Japanese industrial group working across materials, chemicals, electronics, housing and construction, healthcare, and pharmaceuticals. Its research and commercial operations include semiconductor technologies, life sciences, medical devices, and energy solutions such as electrolysis and hydrogen production. The company combines industrial manufacturing with applied research, with sustainability and innovation shaping its work across diverse markets.
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Director of Biostatistics

Lead statistical strategy across clinical development programs at a specialty pharmaceutical company, guiding trial design, CRO partners, analyses, and regulatory submissions.

USUnited StatesNCNorth Carolina
$215,000 – $250,000 / year
HybridFull-timeLeadEnglish RequiredDirector

Description

  • Serve as the lead statistical contact for one or more clinical development programs.
  • Shape clinical development plans, target product profiles, and program strategy with statistical insight.
  • Align statistical approaches across all studies within each program.
  • Guide quantitative decisions on go/no-go criteria, dose selection, and adaptive trial designs.
  • Partner with Clinical Development to design rigorous, efficient trials from first-in-human studies through registration.
  • Review statistical content in protocols, SAPs, and mock TLFs.
  • Recommend methods, estimands, and endpoints that advance program objectives.
  • Oversee statistical and programming work performed by CROs and other external vendors.
  • Keep deliverables on schedule and aligned with quality and regulatory standards.
  • Direct outsourced statistical work, take accountability for its outcomes, and escalate complex issues.
  • Coordinate with Data Management on collection standards, CDISC compliance, and data structures for cross-study analyses.
  • Support integrated database planning and, where relevant, the use of external or real-world data.
  • Plan data needs for interim analyses, adaptive trials, and regulatory discussions.
  • Explain statistical findings to clinical, regulatory, and senior leadership teams.
  • Ensure analyses inform regulatory strategy, publications, safety reviews, and internal decisions.
  • Lead statistical work for IND, CTA, BLA, and MAA submissions.
  • Draft statistical responses to health authority questions and represent statistics at regulatory meetings.
  • Maintain compliance with ICH guidance, regulatory expectations, and clinical statistics best practices.
  • Participate in cross-functional development teams, safety review committees, and governance meetings.
  • Turn complex statistical concepts into practical guidance for non-statistical colleagues.
  • Coach study statisticians and junior team members.

Requirements

  • Master’s or PhD in Biostatistics or Statistics.
  • 10–15 or more years of clinical trial statistics experience in biotech or pharmaceutical settings.
  • Record of leading statistical work across multiple studies or programs.
  • Strong knowledge of ICH, FDA, and EMA guidance and statistical principles for drug development.
  • Advanced SAS expertise.
  • Ability to combine hands-on statistical work with strategic program oversight in a fast-paced biotech environment.
  • Strong communication, leadership, and problem-solving abilities.
  • R familiarity is beneficial.
  • Experience managing CROs and external statistical partners.
  • Experience with adaptive or innovative trial designs.
  • Exposure to early-stage development or rare and complex diseases.
  • Ability to influence senior stakeholders and shape strategic decisions.
  • Collaborative approach and strong focus on scientific and operational quality.
  • Experience applying real-world data to support programs.
  • Experience partnering with Medical Affairs.

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