Manager/Senior Manager of Statistical Programming

We need to output HTML fragment with sections: About Us? The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use

• for any list of duties/requirements/benefits, and

  for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID/requisition numbers as headings — fold minor metadata into a short

  or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences. We need to parse the posting. Content: - About Us: paragraph about Oruka Therapeutics. - Job Title: Manager/Sr Manager of Statistical Programming - Location: Remote or Hybrid if commutable to office in Waltham, MA employee will be required to be in-office 3 days/week. - Role Overview: paragraph. - Key Responsibilities: list of bullet points (each line starts with a verb). We need to put these in

  • . - Qualifications: list of bullet points (multiple lines). We need to put these in
    • . - Skills: appears as "Skills planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines under pressure". That's a sentence; maybe treat as part of Qualifications? But there is a "Skills" heading in the posting? Actually after Qualifications there is "Skills planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines under pressure". It seems like a continuation of Qualifications? The posting includes "Skills" as a line but not a heading. We'll treat it as part of Qualifications or maybe a separate Skills section? The instruction says we can have a Skills section if there is real specific content. There's a sentence about skills. Could make a Skills section with that sentence in

      . But we need to avoid thin sections. However we already have Qualifications which is a list; we could incorporate that sentence into Qualifications as an extra bullet? But it's not a bullet; it's a sentence. Could add as a

      under Qualifications? The instruction: Use

      • for any list of duties/requirements/benefits, and

        for prose. So we can have a Qualifications section with a

        for the bullet list, and then a

        for the skills sentence. Or we could combine into a single

        but we need to preserve all substantive info. Better to keep list as

        and then a

        for the skills sentence. - Compensation: paragraph about salary range. Also there is a line "Salary Range for the Role: $146,000 USD - $187,000 USD". So we have Pay info. We should create a Pay section with that info. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. Yes, they state compensation and salary range. So we need a Pay section. - Benefits: There's a "What We Offer:" section with bullet-like sentences: "A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.", "Competitive salary and benefits package.", "A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.", "Opportunities for professional growth and development." These are benefits. So we should create a Benefits section with

        • . - Schedule: The location line mentions hybrid: "Remote or Hybrid if commutable to office in Waltham, MA employee will be required to be in-office 3 days/week." That's schedule info (in-office 3 days/week). So we can create a Schedule section with that info. - About the role? There's Role Overview paragraph. Could be "About the role" heading. The instruction says use

          for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should have headings: About the role (maybe Role Overview), Responsibilities (Key Responsibilities), Qualifications, Skills, Benefits, Pay, Schedule. Also maybe About Us? Not listed as a standard heading but we could include as a section? The instruction says use those headings as examples; we can also have other headings if needed? It says "use

          for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't forbid other headings, but we should follow the pattern. However we have an "About Us" paragraph that is substantive. Should we include it? The instruction: "Prefer a few substantive sections over many thin ones." Could combine About Us into About the role? But About Us is about company, not role. Could we make a section "About the company"? Not in the list but could be okay. However they said "use

          for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." That suggests those are typical sections; we could also have "About Us" as a heading if we want. But to be safe, we could incorporate About Us into a leading

          before any headings, as introductory paragraph. The instruction: "Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

          or drop it." It doesn't forbid an introductory paragraph. So we can output a

          for About Us, then

          About the role

          with Role Overview paragraph, then

          Responsibilities

          with
          , then

          Qualifications

          with
          plus maybe a

          for skills sentence, then

          Skills

          maybe not needed if we already put skills sentence under Qualifications. But we have a separate skills sentence; we could make a Skills section with that sentence as

          . However that would be a thin section (just one sentence). The instruction says prefer few substantive sections over many thin ones. So better to incorporate that sentence into Qualifications as a

          after the list. That way we avoid a thin Skills section. Thus sections: About Us (intro paragraph), About the role, Responsibilities, Qualifications, Benefits, Pay, Schedule. We must not include sections with filler. All have real content. Now we need to extract exact content, preserving all substantive information, not inventing or summarizing away detail. Let's extract: About Us paragraph: "Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture." We need to preserve all that. Note there is a missing space after ".com As". We'll keep as is. Now Role Overview paragraph: "Oruka Therapeutics is seeking an experienced Manager/Sr Manager of Statistical Programming to lead programming efforts across multiple clinical studies. This role will be instrumental in ensuring high-quality, timely, and compliant statistical deliverables in support of Oruka Therapeutics clinical trials. The ideal candidate will bring deep technical expertise in SAS programming, CDISC standards, and regulatory submission readiness, along with strong leadership and vendor oversight capabilities." Now Responsibilities (Key Responsibilities) list: We need to capture each bullet point exactly as given, preserving punctuation. List: - Lead statistical programming activities for multiple clinical trials within a program or a complete development program - Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). - Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results - Serve as the lead programmer to produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and ad-hoc analyses; write specifications for programming requirements - Oversee CRO SAS programming by providing ongoing review of activities and progress to ensure projects are delivered by the CROs on time with suitable quality - Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports. - Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams - Collaborate with biostatisticians and clinical development colleagues to develop/review TFL shells, SDTM, and ADaM specifications - Identify issues and develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the statistical programming group - Maintain up-to-date advanced knowledge of SAS software as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training - Represent statistical programming at program-level, in audits/inspections and Health Authority (HA) meetings - Offer expert technical and professional recommendations, thought leadership for the statistical programming function at the program level - Adhere to FDA regulations regarding training records, guidelines, and SOPs. Adhere to company SOPs/WIs and department guidelines Note: Some lines end with periods, some not. We'll keep as is. Now Qualifications list: - BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 5+ years in a programming or statistical role - At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs, including the coordination of large teams of internal and/or external programmers - Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met - In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP) - Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs - SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures - Experience with R programming a plus - Must be able to program defensively, check results, and consistently produce accurate outputs - Knowledge of regulatory guidelines (FDA, EMA, ICH) relevant to clinical trials, statistics, and data handling, along with advanced knowledge of submission requirements and standards - Experience in contributing to the review of statistical analysis plans and developing technical programming specifications - Experience with outsourcing programming activities and overseeing services provided by CROs and contractors - NDA submission experience a plus - Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders - The ability to thrive in various situations, enthusiastically embracing organizational changes and evolving job demands Now after that there is a line: "Skills planning and managing multiple responsibilities concurrently