Jobs · New Jersey

Senior Scientist, Stat. Programming, Late-Stage Development (Hybrid)

Merck · Rahway, NJ · 1 mo ago
$117k–$184k/yrFull-time
We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule, Pay etc. Only include sections where there is real specific content. Must not repeat job title heading. Must not include Job ID etc as headings; can fold minor metadata into short

or drop. We need to parse the job description. Key sections: - About the role: description of BARDS, purpose, etc. The first paragraph: "In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle." That's about the role. - Primary Activities: list of bullet points: "Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices", "Maintain and manage a project plan including resource forecasting", "Coordinate the activities of a global programming team that includes outsource provider staff", "Membership on departmental strategic initiative teams". Could be under Responsibilities. - Education: Minimum Requirement: BA/BS plus 5 years SAS OR MS plus 3 years SAS. That's Qualifications/Education. - Required Experience And Skills: Department Required Skills and Experience: list: Effective interpersonal skills and ability to negotiate and collaborate effectively; Effective written, oral, and presentation skills; Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings); A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders. - Position Specific Required Skills And Experience: list: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise; Designs and develops complex programming algorithms; Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts; Familiarity with clinical data management concepts; Experience in CDISC and ADaM standards; Experience ensuring process compliance and deliverable quality; Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices. - Preferred Experience And Skills: list: Working knowledge or R programming languages for data analysis, automation, and clinical data standards activities; Demonstrated success in the assurance of deliverable quality and process compliance; Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC); US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables; Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor; Ability and interest to work across cultures and geographies; Ability to complete statistical programming deliverables through the use of global outsource partner programming staff; Experience developing and managing a project plan using Microsoft Project or similar package; Active in professional societies; Experience in process improvement. - Then there is a line: "BARDS2020 eligibleforERP SPjobs VETJOBS EBRG" seems like tags; ignore. - Required Skills list: "Clinical Development, Clinical Trials, Data Management, Data Modeling, Numerical Analysis, Outcomes Research, Project Leadership, Project Management, SAS Macros, Software Development, Stakeholder Relationship Management, Statistical Programming". Preferred Skills: "R Programming, Team Commitment, Team Player, Willingness to Learn". - Then "Current Employees apply HERE Current Contingent Workers apply HERE" - application instructions, remove. - "US And Puerto Rico Residents Only" - location restriction, maybe part of metadata; could be included as a short p. - EEO boilerplate: remove. - Salary range: "The salary range for this role is $117,000.00 - $184,200.00". That's Pay. - Benefits: "We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days." That's Benefits. - Additional metadata: "Employee Status Regular Relocation: Domestic VISA Sponsorship Yes Travel Requirements 10% Flexible Work Arrangements Hybrid Shift Not Indicated Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 09/25/2026". Could be folded into a short p. We must not include sections with placeholder like "commensurate with experience". Not present. We need to decide which sections to include: About the role, Responsibilities (maybe combine Primary Activities), Qualifications (Education), Skills (maybe combine Required and Preferred), Benefits, Pay. Possibly also a short metadata p. We must not repeat job title as heading. We must use

for section headings. We must use
  • for any list of duties/requirements/benefits, and

    for prose. We must preserve all substantive information; do not invent or summarize away detail. We must not include boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. We must not include Job ID/requisition numbers as headings; fold minor metadata into short

    or drop. Thus we can include a

    for metadata like location restriction, employee status, relocation, visa sponsorship, travel, flexible work, shift, driving license, hazardous material, posting end date. We need to ensure we don't create sections with filler. Let's craft HTML:

    About the role

    In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our Company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

    Responsibilities

    • Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices
    • Maintain and manage a project plan including resource forecasting
    • Coordinate the activities of a global programming team that includes outsource provider staff
    • Membership on departmental strategic initiative teams

    Qualifications

    Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 5 years SAS programming experience in a clinical trial environment OR MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 3 years SAS programming experience in a clinical trial environment.

    Skills

    Required Skills

    • Effective interpersonal skills and ability to negotiate and collaborate effectively
    • Effective written, oral, and presentation skills
    • Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
    • A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
    • Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
    • Designs and develops complex programming algorithms
    • Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts
    • Familiarity with clinical data management concepts
    • Experience in CDISC and ADaM standards
    • Experience ensuring process compliance and deliverable quality
    • Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best‑practices
    • Clinical Development, Clinical Trials, Data Management, Data Modeling, Numerical Analysis, Outcomes Research, Project Leadership, Project Management, SAS Macros, Software Development, Stakeholder Relationship Management, Statistical Programming

    Preferred Skills

    • Working knowledge of R programming languages for data analysis, automation, and clinical data standards activities
    • Demonstrated success in the assurance of deliverable quality and process compliance
    • Strong working knowledge of reporting processes (SOPs) and software development life‑cycle (SDLC)
    • US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
    • Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor
    • Ability and interest to work across cultures and geographies
    • Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
    • Experience developing and managing a project plan using Microsoft Project or similar package
    • Active in professional societies
    • Experience in process improvement
    • R Programming, Team Commitment, Team Player, Willingness to Learn

    Benefits

    We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

    Pay

    The salary range for this role is $117,000.00 - $184,200.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.

    Now metadata: location restriction US and Puerto Rico Residents Only, Employee Status Regular, Relocation: Domestic, VISA Sponsorship Yes, Travel Requirements 10%, Flexible Work Arrangements Hybrid, Shift Not Indicated, Valid Driving License No, Hazardous Material(s) n/a, Job Posting End Date 09/25/2026. We can put in a

    maybe under a heading like "Additional Information" but we should only include heading if real specific content. Could add

    Additional Information

    with a

    . That seems okay. But we must avoid creating sections with filler. This is real info. Let's

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