Director, Biostatistics , Biometric Sciences

We need to output HTML fragment with sections: About the role, Responsibilities, Qualifications, Benefits, maybe Pay? The posting says salary range is commensurate with experience, which is not specific, so we should NOT include Pay section because it's not specific. Schedule: mentions hybrid, remote, office three days a week, travel up to 10% - that's schedule info. Should we include Schedule section? The rule: include a section ONLY when posting has real, specific content for it. It does have schedule info: hybrid, remote, office three days a week, travel up to 10%. That's specific enough. So include Schedule. Benefits: they list benefits. So include Benefits. About the role: we have introductory paragraph describing role. Use

About the role

then

with that prose. Responsibilities: list bullet points. Qualifications: list bullet points? The qualifications are a paragraph with many items separated by periods. Could break into

• each qualification. We'll need to parse. We must not repeat job title. No Job ID. Remove boilerplate: EEO, E-Verify, etc. Also remove duplicated lines. We must preserve all substantive information. Let's extract content. Intro: "At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the Executive Director, Biometric Sciences, the Director, Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies across Viridian’s development programs that are leveraging our cutting-edge Monoclonal antibody science to create transformative medicines for patients. This role is an exciting opportunity to lead and collaborate as a critical part of the clinical development group of a high performing organization. This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management." That's the About the role. Responsibilities: list after "Responsibilities (including, but not limited to):" then bullet points separated by line breaks? The text: "Serve as the biostatistics leader & partner to our clinical development team responsible for determining clinical study strategies and manage teams to deliver results with high quality and on timeChampion in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programsCollaborate with internal and external Data Management stakeholdersCollaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data typesProvide guidance and management to contractors / consultants and manage / mentor supporting members to ensure high quality and timely deliverables.Oversee development of statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analysesPlan, manage, and track biostatistics activities, timelines, and resources and assure operational excellenceFrequently interact with regulatory agencies and effectively address the statistical questions and requestsReview and/or author SOPs and/or Work Instructions related to biostatistics practicesCollaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goalsManage a functional or project budget and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards thereRepresent Viridian at professional societies, and in industry-wide technical discussions" We need to split into sensible bullet points. Likely each sentence separated by a capital letter after a period. Let's manually split: - Serve as the biostatistics leader & partner to our clinical development team responsible for determining clinical study strategies and manage teams to deliver results with high quality and on time - Champion in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs - Collaborate with internal and external Data Management stakeholders - Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types - Provide guidance and management to contractors / consultants and manage / mentor supporting members to ensure high quality and timely deliverables. - Oversee development of statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses - Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence - Frequently interact with regulatory agencies and effectively address the statistical questions and requests - Review and/or author SOPs and/or Work Instructions related to biostatistics practices - Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals - Manage a functional or project budget and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards there - Represent Viridian at professional societies, and in industry-wide technical discussions Note some grammar issues but keep as is. Qualifications: after "Qualifications:" then paragraph: "PhD (or equivalent degree) with 8+ years of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 12+ years of relevant experienceExcellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems. Experience in Rare Diseases therapeutics clinical development is preferredProficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulationWorking knowledge of relevant FDA, EU, ICH guidelines and regulationsExtensive experience and excellent skillsets in managing teams and engagement of CROs, vendors, and relationship management preferredDemonstrated proficiency in statistical processes including but not limited to CRF review, development of randomization lists, development of statistical analysis plan, development of CDISC submission package (SDTM, ADaM, define xml, reviewer guides), development of analysis output and review of clinical study reportExperience in managing external vendorsPrior experience supporting one or more successful BLA, NDA or MAA submissions and participating in regulatory agency meetings is strongly preferredOutstanding communication skills (verbal and written)Ability to manage multiple projects in a fast-paced environmentAbility to effectively collaborate in a dynamic, cross-functional matrix environmentStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Ability to travel up to 10%" We need to split into bullet points. Let's parse sentences: - PhD (or equivalent degree) with 8+ years of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. - MS (or equivalent degree) with 12+ years of relevant experience - Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems. - Experience in Rare Diseases therapeutics clinical development is preferred - Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation - Working knowledge of relevant FDA, EU, ICH guidelines and regulations - Extensive experience and excellent skillsets in managing teams and engagement of CROs, vendors, and relationship management preferred - Demonstrated proficiency in statistical processes including but not limited to CRF review, development of randomization lists, development of statistical analysis plan, development of CDISC submission package (SDTM, ADaM, define xml, reviewer guides), development of analysis output and review of clinical study report - Experience in managing external vendors - Prior experience supporting one or more successful BLA, NDA or MAA submissions and participating in regulatory agency meetings is strongly preferred - Outstanding communication skills (verbal and written) - Ability to manage multiple projects in a fast-paced environment - Ability to effectively collaborate in a dynamic, cross-functional matrix environment - Strong commitment to ethical standards - Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) - Ability to travel up to 10% Note "Ability to travel up to 10%" appears also in schedule but it's also in qualifications; we keep it. Benefits: after "Viridian offers a comprehensive benefits package including:" then list: - Competitive pay and stock options for all employees - Competitive medical, dental, and vision insurance - 100% Paid Parental Leave - Short- and long-term disability coverage - Life, Travel and AD&D - 401(k) Company Match with immediate company vest - Employee Stock Purchase plan - Generous vacation plan and paid company holiday shutdowns - Various fertility, mental, financial, and proactive physical health programs Schedule: we have hybrid/remote info: "This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management. Ability to travel up to 10%" We can combine into schedule bullet points. Now produce HTML:

  About the role

  ... (the intro paragraph)

  Responsibilities

  • ...
  ...

  Qualifications

  • ...
  ...

  Benefits

  • ...
  ...

  Schedule

  • Hybrid role based at Waltham, MA headquarters or fully remote
  • Office-based employees required to work in the office three days per week
  • Remote employees may be required to travel to headquarters for meetings at management's discretion
  • Ability to travel up to 10%
  We must not include Pay section because salary range is commensurate with experience (not specific). Good. Check for any leftover boilerplate: removed EEO, E-Verify, etc. Make sure no markdown fences. Just raw HTML. Let's craft the intro paragraph exactly as given but maybe trim trailing spaces. Intro paragraph: "At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the Executive Director, Biometric Sciences, the Director, Biostatistics will be involved in the design, execution, analysis, and reporting clinical studies across Viridian’s development programs that are leveraging our cutting-edge Monoclonal antibody science to create transformative medicines for patients. This role is an exciting opportunity to lead and collaborate as a critical part of the clinical development group of a high performing organization. This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management." Note we moved schedule details to Schedule section; but the intro currently includes those lines. To avoid duplication, we should maybe keep intro without schedule details, but the rule says preserve ALL substantive information; we can keep them in intro and also schedule? That would duplicate. Better to keep intro generic and move schedule details to Schedule section, but we must not lose info. We can keep intro without the schedule sentences, but then we lose that info unless we put it in Schedule. So we should edit intro to exclude those schedule sentences, and place them in Schedule. Let's craft intro without those sentences. Intro: "At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the