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Asahi Kasei
Asahi Kasei
H1B वीज़ा प्रायोजकखाद्य और पेयनिर्माणस्वास्थ्य सेवा
Asahi Kasei एक जापानी औद्योगिक समूह है, जो सामग्री, रसायन, इलेक्ट्रॉनिक्स, आवास और निर्माण, स्वास्थ्य सेवा तथा औषधि जैसे क्षेत्रों में काम करता है। इसके अनुसंधान और व्यावसायिक संचालन में सेमीकंडक्टर प्रौद्योगिकियाँ, जीवन विज्ञान, चिकित्सा उपकरण और इलेक्ट्रोलिसिस तथा हाइड्रोजन उत्पादन जैसे ऊर्जा समाधान शामिल हैं। कंपनी विभिन्न बाजारों में औद्योगिक विनिर्माण और अनुप्रयुक्त अनुसंधान को जोड़ती है, जबकि स्थिरता और नवाचार इसके कार्य को दिशा देते हैं।
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कंपनी की नौकरियाँ

Director of Biostatistics

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

USसंयुक्त राज्यNCउत्तरी कैरोलिना
$2,15,000 – $2,50,000 / वर्ष
हाइब्रिडपूर्णकालिकलीडआवश्यक भाषा: अंग्रेज़ीनिदेशक

विवरण

  • 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.

आवश्यकताएँ

  • 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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