Jobs · Research · California

Lead Biostatistician (Oncology Clinical Studies)

Natera · San Carlos, CA · 1 mo ago
Research$144k–$180k/yrFull-time
We need to produce HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. No Job ID etc. Remove boilerplate. Preserve all substantive info. Use
  • for any list of duties/requirements/benefits. Use

    for prose. We need to extract content. The posting includes: - Intro paragraph: "This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio. The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment." That could be "About the role" section. Then "Primary Responsibilities" with sub-bullets: Study Design and Statistical Strategy, Cross-Functional Collaboration, Documentation and Reporting, Innovation and Improvement. Each has bullet points. We need to list responsibilities as

    • . Probably each bullet is a responsibility. Then "Qualifications" section: bullet list of qualifications. Then "Knowledge, Skills, And Abilities" maybe separate "Skills" section. Then "Preferred qualifications:" maybe part of Qualifications or Skills. Then "Compensation & Total Rewards": includes description and bullet list of benefits, plus compensation range. We need separate sections: Benefits, Pay, Schedule. Schedule not mentioned, so omit. Pay: we have compensation range $144,000—$180,000 USD. Also mention final compensation varies etc. Should we include that as Pay section? Yes. Benefits: list of benefits: Annual performance incentive bonus, Long-term equity awards, Comprehensive health benefits (medical, dental, vision), 401(k) with company match, Generous paid time off and company holidays, Additional wellness and work-life benefits. Also later "What We Offer Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!" That's more benefits. We need to preserve all substantive info, not invent. So we should combine benefits lists, avoid duplication? We should preserve all, but can combine similar items. The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." So we should not omit any benefit mentioned. We can list them in a
        with each distinct benefit. Duplication okay? Might be okay but better to avoid duplicate lines. We'll list each unique benefit. Let's extract benefits from both sections: From "Compensation & Total Rewards": - Annual performance incentive bonus - Long-term equity awards - Comprehensive health benefits (medical, dental, vision) - 401(k) with company match - Generous paid time off and company holidays - Additional wellness and work-life benefits From "What We Offer Competitive Benefits": - Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents - Free testing for employees and immediate families (in addition to fertility care benefits) - Fertility care benefits (mentioned) - Pregnancy and baby bonding leave - 401k benefits (maybe duplicate of 401(k) with company match) - Commuter benefits - Generous employee referral program Also earlier: "Comprehensive health benefits (medical, dental, vision)" already covered. We need to avoid duplication but preserve all. We'll combine similar items: e.g., comprehensive health benefits (medical, dental, vision) plus life and disability plans. So we can list "Comprehensive health benefits (medical, dental, vision, life and disability)" as one. Free testing for employees and immediate families (in addition to fertility care benefits) and fertility care benefits: maybe combine as "Free testing and fertility care benefits for employees and immediate families". Pregnancy and baby bonding leave. Commuter benefits. Employee referral program. 401(k) with company match (already). Generous paid time off and company holidays. Additional wellness and work-life benefits. Annual performance incentive bonus. Long-term equity awards. We should also include "Competitive Benefits" phrase? Not needed. Now Pay: compensation range $144,000—$180,000 USD. Also note "Final compensation will vary based on experience, qualifications, and internal equity considerations." Also "This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program". That's more about benefits. We'll keep Pay section with range and note about variability. Schedule: none, omit. Now Skills: from "Knowledge, Skills, And Abilities" bullet list: - Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges. - Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation. - Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds. - Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences. Also "Preferred qualifications:" includes: - Working-knowledge of NGS-based diagnostics and ctDNA/MRD. - Experience with non-inferiority studies. These could go under Skills or Qualifications. Since they are "Preferred qualifications", we could include them in Qualifications section as additional bullet points. Qualifications section includes: - Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred). - 4+ years of experience in clinical trial biostatistics. - Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology. - Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation. - Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM). - Proficient in R. We'll also add the preferred qualifications as part of Qualifications (maybe separate but still qualifications). We'll keep them. Now we need to output HTML fragment with headings

        for each section we include. Sections: About the role, Responsibilities, Qualifications, Skills, Benefits, Pay. We should not include Schedule. Now we need to ensure we don't include boilerplate like EEO, scam warning, etc. Remove those. Now produce HTML. Structure:

        About the role

        ... intro paragraph ...

        Responsibilities

        • Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.
        • Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.
        • Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders.
        • Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor. Collaborate on manuscripts for publications.

        Qualifications

        • Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).
        • 4+ years of experience in clinical trial biostatistics.
        • Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.
        • Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.
        • Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).
        • Proficient in R.
        • Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
        • Experience with non-inferiority studies.

        Skills

        • Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.
        • Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.
        • Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.
        • Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.

        Benefits

        • Annual performance incentive bonus
        • Long-term equity awards
        • Comprehensive health benefits (medical, dental, vision, life and disability)
        • 401(k) with company match
        • Generous paid time off and company holidays
        • Additional wellness and work-life benefits
        • Free testing and fertility care benefits for employees and immediate families
        • Pregnancy and baby bonding leave
        • Commuter benefits
        • Generous employee referral program

        Pay

        Compensation range: $144,000—$180,000 USD. Final compensation will vary based on experience, qualifications, and internal equity considerations.

        Check for any missing substantive info: The intro also mentions "As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials." Already covered. Also "You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio." Included in responsibilities bullet. Also "The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment." This is somewhat covered in qualifications/skills but we could add to About the role? Already we have intro paragraph that includes that sentence? Actually we omitted that sentence. Let's include it in About the role paragraph. We need to preserve ALL substantive information. So we should include that sentence. Let's craft About the role paragraph: "This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio. The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment." That's good. Now ensure we didn't miss any responsibilities: The bullet list we made covers each heading under Primary Responsibilities. Good. Check if any other responsibilities like "Collaborate on manuscripts for publications." included in Innovation and Improvement bullet. Now check if any other qualifications like "Proficient in R." included. Now check if any other skills like "Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation." included. Now check if any other benefits like "Comprehensive medical, dental, vision,

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