Jobs · Analyst · New Jersey

Director, Biostatistics

Eisai US · Nutley, NJ · 1 mo ago
Analyst$205k–$269k/yrFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info, not invent or summarize away detail. Remove boilerplate like EEO, E-Verify, etc. Also remove application instructions. We need to parse the posting. Let's extract content: First paragraph: "At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you." That's about the company and role. Could be "About the role" or maybe "About Eisai". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can put the introductory paragraph under

About the role

as prose. Next: "This position serves a critical role within the clinical development in that he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis datasets and coauthoring manuscripts. In addition, this position would work with statisticians on process development, internal contractor oversight, and various team management and development tasks." That seems like responsibilities. But then there is a "Responsibilities:" heading later with bullet list. We should combine? The instruction: Use
  • for any list of duties/requirements/benefits. So we need to extract list items. The "Responsibilities:" section includes a paragraph then bullet-like sentences separated by line breaks? Let's see: "Responsibilities: Translate the strategic departmental goals into operational goals for the teams, working across different phases of studies, for one or more compound Manage multiple/large/complex biostat projects/ studies through operational oversight of deliverables of the team i.e validate TLGs and analysis datasets, coauthor manuscripts, support regulatory interaction, develop/ review of study documents, statistical analysis plan, final study report etc.Work cross-functionally with internal cross functional teams (i.e clinical, project management, data management etc.) and CROs/ vendor teams to drive strategic study design, collaboration, proactively managing risks etc.Function as lead statistician in global registration trials and manage all related statistical activitiesUnderstand the talent capabilities within biostatistics team and set up processes to drive developmentLead global submission activities, acting as a functional and technical expert to support submission strategy planning and regulatory communicationDrive innovative and efficient study design by developing study designs that address study objectives and support clinical development & regulatory approvalLead the evaluation and selection of strategic/ large vendor partners while ensuring synergies and operational efficiencyContribute to SOPs/ templates/ and working instructions related to EDC studies, FDA requests, independent validation, and general biostatistic processes(People Leaders/ Directors) Lead a team of biostatistics experts through goal planning, performance management, engagement and development of the team; Support in budget management for own area" That's a long paragraph with semicolons etc. It's not clearly bullet list but we can treat each clause as a duty. However instruction: Use
    • for any list of duties/requirements/benefits. If the posting does not have explicit bullet list, we could still convert sentences into list items? The instruction says "for any list of duties/requirements/benefits". If it's not a list, we could use

      . But we could also split into list items for clarity. However we must not invent or summarize away detail. Splitting into list items is not inventing; it's just formatting. It preserves detail. Probably acceptable. Similarly "Qualifications:" section: "Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred.Ph.D. in Biostatistics or related areaExperience directing multiple complex projects from end to end as a subject matter expert for own area (immunogenicity, biomarkers, safety etc.) in BiostatisticsStrong publication record demonstrating relevant experienceDemonstrated experience in applying statistical skills across multiple areas of pharmaceutical biostatistics, with broad understanding and experience of the clinical development processExperience building internal/ external networks and contributing as thought leader in own area(People Leaders/ Directors) Experience directly leading/managing a team through operational oversight including budget & resourcesProven performance in earlier role/comparable role Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred." There's duplication. We need to preserve all substantive info, but we should not repeat duplicated lines. So we need to deduplicate. The qualifications appear repeated twice. We'll keep unique items. "Skills:" section: "Biostatistics Skills, Communication & Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management, Statistical Programming Skills, Vendor Management" That's a list. Pay: "Eisai Salary Transparency Language: The annual base salary range for the Director, Biostatistics is from :$205,000-$269,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. Certain other benefits may be available for this position, please discuss any questions with your recruiter." We need Benefits and Pay sections. Benefits: mention of employee benefit programs, incentive plans. The posting mentions eligibility to participate in Annual Incentive Plan & Long Term Incentive Plan, and employee benefit programs. Also "Certain other benefits may be available". So we can create a Benefits section with those details. Pay: salary range. Schedule: not mentioned. So we should not include Schedule section. Also we need to remove boilerplate: EEO, E-Verify, Right To Work, etc. Also remove application instructions (none present). Also remove duplicated lines. Now construct HTML. We'll have:

      About the role

      At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. This position serves a critical role within the clinical development in that he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis datasets and coauthoring manuscripts. In addition, this position would work with statisticians on process development, internal contractor oversight, and various team management and development tasks.

      Then Responsibilities:

      Responsibilities

      • Translate the strategic departmental goals into operational goals for the teams, working across different phases of studies, for one or more compound
      • Manage multiple/large/complex biostat projects/studies through operational oversight of deliverables of the team (e.g., validate TLGs and analysis datasets, coauthor manuscripts, support regulatory interaction, develop/review study documents, statistical analysis plan, final study report, etc.)
      • Work cross-functionally with internal cross-functional teams (e.g., clinical, project management, data management) and CROs/vendor teams to drive strategic study design, collaboration, proactively managing risks
      • Function as lead statistician in global registration trials and manage all related statistical activities
      • Understand the talent capabilities within the biostatistics team and set up processes to drive development
      • Lead global submission activities, acting as a functional and technical expert to support submission strategy planning and regulatory communication
      • Drive innovative and efficient study design by developing study designs that address study objectives and support clinical development & regulatory approval
      • Lead the evaluation and selection of strategic/large vendor partners while ensuring synergies and operational efficiency
      • Contribute to SOPs/templates/working instructions related to EDC studies, FDA requests, independent validation, and general biostatistic processes
      • (People Leaders/Directors) Lead a team of biostatistics experts through goal planning, performance management, engagement and development of the team; support in budget management for own area
      Qualifications: we need to decide heading. The instruction includes "Qualifications" as a possible heading. We'll use

      Qualifications

      . Provide list items. We need to extract unique qualifications: - Bachelor's degree (Master's preferred) and 10+ years of relevant experience. - Experience in Life Sciences industry preferred. - Ph.D. in Biostatistics or related area. - Experience directing multiple complex projects from end to end as a subject matter expert for own area (immunogenicity, biomarkers, safety etc.) in Biostatistics. - Strong publication record demonstrating relevant experience. - Demonstrated experience in applying statistical skills across multiple areas of pharmaceutical biostatistics, with broad understanding and experience of the clinical development process. - Experience building internal/external networks and contributing as thought leader in own area. - (People Leaders/Directors) Experience directly leading/managing a team through operational oversight including budget & resources. - Proven performance in earlier role/comparable role. Note: The duplicated "Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred." appears twice; we keep once. We'll list as
      • ...
      • . Skills: list.

        Skills

        • Biostatistics Skills
        • Communication & Cross-functional Influence
        • Critical Thinking & Business Agility
        • Industry/Regulatory Knowledge
        • Mentoring/People Development
        • Project Management
        • Statistical Programming Skills
        • Vendor Management
        Benefits: we need to capture eligibility for incentive plans and employee benefit programs. We'll create

        Benefits

        Eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs. Certain other benefits may be available for this position; discuss any questions with your recruiter.

        Pay: salary range.

        Pay

        The annual base salary range for the Director, Biostatistics is $205,000–$269,100. Final pay determinations will depend on various factors including experience level, education, knowledge, and skills.

        We should not include the link to benefits page? The instruction: preserve ALL substantive information; do not invent or summarize away detail. The link is substantive? It's a reference for additional info. Could keep as part of Benefits paragraph maybe. But we might keep it as a link. However the instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The link is not boilerplate; it's a reference to benefits. We could keep it. But we might

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