Associate Principal Scientist, Statistical Programming, Late-Stage Oncology (Hybrid)
$142.4k - $224.1kMerck
Job Description 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 leads the statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development 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. Primary Activities 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. Education And Minimum Requirement BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 9 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 7 years SAS programming experience in a clinical trial environment. Department Required Skills And Experience 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). Leads large and/or complex projects, effectively balances competing priorities, and collaborates closely with key stakeholders to achieve project objectives. Position Specific Required Skills And Experience 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. US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables 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. Ability to anticipate stakeholder requirements. Preferred Skills And Experience Experience with GenAI tools (e.g., Python, R, R Shiny, Claude, etc.). Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC). 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.
BARDS2020
eligibleforERP SPjobsVETJOBS
EBRG Required Skills Base SAS, Competency Management, Computer Programming, Data Management, Data Modeling, Global Regulatory Submissions, Influencing Skills, Numerical Analysis, Presentation Delivery, Process Implementations, Process Improvements, Project Planning, Project Strategy, Regulatory Submissions, Report Creation, Resource Planning, Stakeholder Management, Stakeholder Relationship Management, Statistical Analysis, Statistical Programming, Statistics, Strategic Planning, Strategic Thinking, Structured System Analysis, Waterfall Model Preferred Skills Leadership, Oncology, Oncology Trials, Python (Programming Language), R Programming US And Puerto Rico Residents Only Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. Requirements As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts Primary location for this posting is USA - New Jersey - Rahway Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $142,400.00 - $224,100.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 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. More information about benefits is available at Additional location(s) Please note the salary range above applies to the Primary Location of this role. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. San Francisco Residents Only We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance 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 10/31/2026 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R422057 #J-18808-Ljbffr Merck$117k - $184.2k
...Senior Scientist role in statistical programming supporting late-stage oncology clinical development within the Biostatistics and Research Decision Sciences department. Responsibilities include developing analysis datasets and reporting deliverables, managing statistical...Suggested$142.4k - $224.1k
...Associate Principal Scientist role overseeing submission data standards quality management for regulatory... ...across global clinical development programs. Responsibilities Oversee... ...standards best practice forums Serve as statistical programming point of contact and...PrincipalWorldwide$142.4k - $224.1k
...Development division, quantitative scientists, in partnership with other... ...global human health. The Associate Principal Statistical Programmer, Submission... ...with statistical programming, statistics, regulatory and... ...Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid...PrincipalFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
...Principal Scientist role in Biostatistics leading late-stage clinical development projects. Provides statistical expertise for drug and vaccine development, manages cross-functional teams... ...Lead statisticians and statistical programming staff to meet regulatory and...PrincipalWorldwide- Role: Lead statistical safety evaluation within the CSS group for Oncology Therapeutic Area programs, providing scientific expertise and strategic... ...of drug development stages from preclinical to post-marketing... ...Safety Teams. Work setup: hybrid in the US with...Principal
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...globe. We have an exciting opportunity for a new Associate Principal Scientist to join our Oncology health economic modeling team in the Health Economic... ...including Rahway, NJ; Boston, MA; the UK, and Switzerland. Hybrid and flexible work arrangements are possible,...PrincipalFull timeFor contractorsWork experience placementWork at officeLocal areaFlexible hours$231.9k - $365k
...our varied pipeline of oncology, immunology, vaccines,... ...collaborative team of scientists (12 anatomic... ...early discovery through late‑stage development. Our team... ...collaborative works with multiple program development teams. Key... ...work in a hybrid work environment and routinely...PrincipalFull timeFor contractorsLocal area- Role Principal Scientist in High-Content Imaging within Johnson & Johnson's Innovative Medicine... ...discovery in Immunology, Neuroscience, and Oncology. Responsibilities include developing,... ...collaborations, data integration, and programming in R/Python; familiarity with AI/ML...Principal
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...Postdoctoral Research Fellow Program Our Research Laboratories' Postdoctoral... ...with a collaborative team of scientists in quantitative pharmacology,... ...biology, systems biology, statistics / biostatistics, mathematics... ...Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid...RelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
...accomplished and highly motivated Principal Scientist (Director) to serve as an... ..., directly informing program- and portfolio-level decisions... ...discovery, early- and late-stage clinical programs, ensuring... ...Immunology Research, Immuno-Oncology, Inflammatory Diseases, Omics...PrincipalFull timeFor contractorsLocal areaFlexible hours$117k - $201.25k
...recruiting for the role of "Principal Scientist - AI-Reasoning for... ...areas encompass oncology, cardiovascular and retina... ...applied mathematics, statistics) with 2+ years of... ...applications Exceptional Python programming skills, capable of... .... #LI-GR1 #LI-Hybrid #JRDDS...PrincipalLocal areaImmediate startWorldwideShift work- ...first mindset. As a Principal Scientist in the Predictive... ...intersection of late-phase CMC process... ...mechanistic, hybrid and data-driven models... ..., Computer Programming, Data Analysis, Data... ...Predictive Modeling, Statistical Models Please... ...and inflammation; oncology; HIV; and...PrincipalLocal areaShift work
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...Associate Principal Scientist position focused on health economic modeling for oncology products within the Health Economic and Decision Sciences group. The role involves developing predictive and economic models, collaborating with cross-functional teams, and communicating...PrincipalWork experience placement- ...is seeking a Lead statistician to oversee safety analyses in Oncology programs as part of the CSS group, providing scientific expertise and... ...to design and interpret safety analyses, develop innovative statistical methods and tools for safety monitoring, and communicate...Principal
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...The Regulatory Affairs Headquarters Associate Principal Scientist supports products in the Vaccine and... ...compliance and life cycle management) of VID programs. Supports of Global Liaison in label... ...Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License...PrincipalFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
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...Manager to oversee scientific strategy and data integrity for late-stage oncology clinical trials. The role involves protocol development,... ...monitoring, and cross-functional partnership to advance oncology programs from phase 3 through approval. Responsibilities Serve...Work at office$255.8k - $402.7k
...opportunity for a physician-scientist to join our group as a Principal Scientist (Clinical... ...discovery scientists and late-stage clinical researchers. The... ...pharmacology studies for programs in all phases (I - IV) of... ...Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid...PrincipalFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- ...Job Description Senior Scientist in AI and... ...Discovery and Manufacturing Statistics organization within Johnson... ...the proof‑of‑concept stage to validated statistical... ...workflows. RAG evaluation, hybrid retrieval, knowledge... ...Systems (SAS) Programming, Statistics, Systems Development...
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...advance development programs and maintain licensure... ...professionalism. The Senior Principal Scientist, Regulatory Affairs... ...in early- and/or late-stage development. Programs... ...Director or Associate Vice President, General... ...Flexible Work Arrangements Hybrid Shift Not Indicated...PrincipalLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
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...a dynamic and collaborative scientist for the Drug Metabolism and... ...Pharmacokinetics (DMPK) group. The Principal Scientist will be a key... ...profile. They will assess program risks including DDI, metabolism... ...ability to support early to late stage clinical development...PrincipalFull timeFor contractorsLocal areaFlexible hours- Johnson & Johnson is offering a Global Oncology Internship Program in Spring House, PA. This 12-week, full-time internship combines hands-on lab... ...research at a symposium and interact with senior leadership. Hybrid work arrangement applies. #J-18808-Ljbffr Johnson &...Full timeInternship
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...are seeking a Discovery Program Leader (DPL) to... ...primarily on immunology and oncology. This position... ...assess potential risks associated with therapeutic targets... ...a non-clinical safety scientist (e.g. Toxicology, Pathology... ...Work Arrangements: Hybrid Shift: 1st - Day Valid...PrincipalFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- ...& Co., Inc. in the United States is seeking an Associate Principal Scientist to advance biologics pipeline programs. You will lead process characterization, scale-... ...transfer and process validation activities to support late-stage and commercial products. The role requires deep...Principal
- Merck is seeking an experienced statistical programmer lead within BARDS to drive analysis and reporting across late-stage drug/vaccine programs. You will design, implement, and validate complex datasets, tables, listings, and figures for regulatory submissions and post...
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