Vice President, Biometrics (Consultant)

We need to output HTML fragment with sections: headings using

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections where there is real specific content. We need to parse the posting. The posting includes: - Reporting to CMO, integral team member, exposure to multiple facets of business operations. (intro paragraph) - The Vice President, Biometrics (Consultant) will be accountable for ensuring that clinical evidence generation, data quality, statistical strategy, submission readiness, and biometrics operations are aligned with Company strategy, portfolio priorities, regulatory requirements, and capital-efficient execution. - Serve as senior biometrics rep to global health authorities, partners, KOLs, other stakeholders. - Elicio Therapeutics (ELTX) is a growing organization based out of the Seaport area of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States. Then "Major Duties/Responsibilities" heading with bullet list. Then "Required Education & Professional Experience" with bullet list. Then "Working Conditions: ..." etc. Then "Travel: ..." Then "Physical Requirements: ..." Then "Work Location: ..." Then "Work Status: ..." Then "Compensation Range: Hourly bill rate of $225.00 - $325.00." Then "About Elicio Therapeutics" paragraph. Then "About The Amphiphile Platform" paragraph. We need to remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. There's none. We need to produce sections: maybe "About the role" (intro), "Responsibilities" (major duties), "Requirements" (education/experience), "Qualifications" maybe overlapping? Could combine. "Skills" maybe from required skills. "Pay" from compensation range. "Schedule" maybe not present. "Benefits" not present. "Work Location" maybe could be part of "About the role" or separate? The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map content to these headings where appropriate. We need to include a section only when posting has real, specific content for it. So we need to decide which sections have content. - About the role: we have intro paragraph describing reporting to CMO, integral team member, exposure to multiple facets, etc. Also description of company location. That fits. - Responsibilities: we have major duties list. - Requirements: we have required education & professional experience list. - Qualifications: maybe could be same as requirements? But we could treat qualifications as the list of skills/experience like leadership, communication, etc. The posting includes "Excellent communication, written, and interpersonal skills; demonstrated strong leadership skills and ability to solve complex issues and collaborate effectively with cross-functional teams. Strong team player with the ability to work in a fast-paced environment, manage competing priorities, while filling gaps as needed. Recent experience in oncology; pancreatic cancer experience Experience working in small pharmaceutical/biotech companies Familiar with ICH guidelines, FDA, EMA, and requirements of global regulators. NDA/BLA experience including eCTD submissions in oncology". That could go under Qualifications or Skills. We'll decide. - Skills: maybe we can extract specific skills: communication, leadership, strategic thinking, statistical methods, etc. But we might combine. - Pay: we have compensation range. - Schedule: not mentioned. - Benefits: not mentioned. - Working Conditions, Travel, Physical Requirements, Work Location, Work Status: these are not in the prescribed headings list, but we could fold them into About the role or maybe a separate section like "Details". However instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It implies we should use those headings where appropriate, but we could also add other headings if needed? It says "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." That suggests those are the allowed headings. Probably we should stick to those. So we need to map all relevant info into those sections. Thus we need to include About the role, Responsibilities, Requirements, Qualifications, Skills, Pay. Possibly also Benefits if none, skip. Schedule if none, skip. We need to avoid filler like "commensurate with experience". Not present. Now we need to preserve all substantive information. So we need to ensure we don't lose any details. Let's extract content: Intro paragraph (About the role): - Reporting to the Chief Medical Officer, this individual will serve as an integral team member with exposure to multiple facets of business operations. - The Vice President, Biometrics (Consultant), will be accountable for ensuring that clinical evidence generation, data quality, statistical strategy, submission readiness, and biometrics operations are aligned with Company strategy, portfolio priorities, regulatory requirements, and capital-efficient execution. - The Vice President, Biometrics (Consultant) will serve as the Company’s senior biometrics representative to global health authorities, partners, key opinion leaders, and other stakeholders. - Elicio Therapeutics (ELTX) is a growing organization based out of the Seaport area of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States. That's the role description. Responsibilities (Major Duties/Responsibilities): List items: - Oversees the planning and execution of biostatistics, and statistical programing activities in support of clinical development plans, clinical trials, regulatory approval, and marketing goals aligned to corporate goals. - Builds, leads and manages an effective biostatistics team including the development of standard department operating processes, and mentors junior staff. - Provides strategic and technical leadership and supervision to a multidisciplinary team and responsible for the design, development, and/or implementation of innovative statistical methods, data and programming operations. - Responsible for the overall quality of all biostatistics, statistical programming, and all relevant deliverables. - Provides input to cross functional teams in making the best decisions and capable to articulate complex statistical concepts into lay language; makes timely and calculated decisions to change the course of action when necessary. - Lead the selection of CROs (external vendors) for outsourced biometrics activities; accountable for costs, timeliness, and quality of the deliverables. - Utilize the experience with the regulatory submission process and represents the company at meetings with global regulatory health authorities, including extensive engagement in the discussions with and present company’s positions at meetings with FDA, EMA and/or other regulatory agencies. - Apply the comprehensive understanding of the oncology disease landscape of interests which includes but not limited to trial designs, competitions, operational understanding of HEOR and reimbursement requirements. - Advise and support publication strategy, scientific presentations, and the assessment of translational laboratory data. - May engage in strategic discussions with senior management, advisory boards, and key opinion leaders on topics relevant to the product candidates. - Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team. - Partner with Clinical Development and Regulatory Affairs to shape integrated global development plans, including target product profiles, indication strategy, endpoint selection, control-arm strategy, estimands, statistical assumptions, and confirmatory evidence plans. - Provide independent, data-driven recommendations on portfolio prioritization, clinical program advancement, indication expansion, go/no-go decisions, protocol amendments, and risk-mitigation strategies. - Establish biometrics governance forums and decision-making processes to ensure timely escalation and resolution of critical risks related to data integrity, statistical validity, database readiness, endpoint reliability, and submission readiness. - Define departmental performance metrics and regularly report on quality, delivery, budget, resource utilization, regulatory readiness, and key program risks to executive leadership. That's a lot. Requirements (Required Education & Professional Experience): - MS or PhD in statistics, biostatistics or related field with a minimum of 15 years of experience in Pharma and/or Biotech. - Extensive clinical trial experience including randomized time to event data, and a minimum of 10 years in leadership roles. - Excellent communication, written, and interpersonal skills; demonstrated strong leadership skills and ability to solve complex issues and collaborate effectively with cross-functional teams. - Strong team player with the ability to work in a fast-paced environment, manage competing priorities, while filling gaps as needed. - Recent experience in oncology; pancreatic cancer experience - Experience working in small pharmaceutical/biotech companies - Familiar with ICH guidelines, FDA, EMA, and requirements of global regulators. - NDA/BLA experience including eCTD submissions in oncology Note: Some of these are skills/qualifications. We'll split. Qualifications: maybe we can treat the education/experience as Requirements, and the skills/competencies as Qualifications. But the instruction says we can have both Requirements and Qualifications sections. We need to avoid duplication. Let's assign: Requirements: education and years experience (MS/PhD, 15 years experience, 10 years leadership). Also maybe "Extensive clinical trial experience including randomized time to event data". That's experience. Qualifications: skills like communication, leadership, team player, fast-paced, oncology experience, small pharma experience, ICH guidelines familiarity, NDA/BLA eCTD submissions. Skills: maybe we can extract specific technical skills: statistical strategy, biostatistics, statistical programming, innovative statistical methods, data and programming operations, regulatory submission process, oncology disease landscape, HEOR/reimbursement, publication strategy, scientific presentations, translational lab data assessment, strategic discussions, cross-functional collaboration, governance forums, performance metrics, etc. But that overlaps with responsibilities. Better to keep Skills short: maybe list "Strategic leadership, statistical methodology, regulatory submission, cross-functional communication, team management, CRO vendor selection, oncology expertise, HEOR/reimbursement knowledge, publication strategy, data-driven decision making". But we must not invent details; we need to preserve all substantive information. If we create a Skills section, we must ensure we don't lose any info that is only in other sections. We could move some items from Requirements/Qualifications to Skills, but we must keep them somewhere. Simplify: Use Requirements for education/experience. Use Qualifications for skills/competencies (communication, leadership, etc.). Use Skills maybe empty -> skip. But we could also put some of the technical skills under Skills. However we risk duplication. Given instruction: "Prefer a few substantive sections over many thin ones." So better to have fewer sections: About the role, Responsibilities, Requirements (covering education/experience and key qualifications), Pay. That's four sections. That seems acceptable. But we need to include Qualifications and Skills if we have content. However we can incorporate qualifications into Requirements. The instruction says we can use those headings; not required to use all. So we can omit Qualifications and Skills if we fold content into Requirements. Thus final sections: About the role, Responsibilities, Requirements, Pay. Check if any content left out: Working Conditions, Travel, Physical Requirements, Work Location, Work Status, About Elicio Therapeutics, About The Amphiphile Platform. Those are substantive. Should we include them? They are not covered by the headings list, but we could fold them into About the role or maybe a separate "About the company" section. However the instruction only gave examples; not strict that we cannot add other headings. It says "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." The "e.g." suggests those are examples, not an exhaustive list. So we could add other headings like "About the company" or "Work details". But to be safe, we could incorporate company description into About