Scientist, Statistical Programming

Marketing Pipelines Leadership Management Innovation Statistics Compassion SAS Macros Forecasting Decisiveness Life Sciences Biostatistics Data Modeling Collaboration Accountability SAS (Software) Data Integrity Clinical Trials Data Management Project Planning Computer Science Telephone Skills Decision Science Microsoft Project Outcomes Research Shiny (R Package) Project Management Numerical Analysis Applied Mathematics Program Development Reporting Processes Project Stakeholders Statistical Analysis Contingent Workforce Programming Languages Emerging Technologies Electronic Submission Statistical Programming Relationship Management Research And Development Pre-Clinical Development Clinical Data Management R (Programming Language) Stakeholder Requirements Stakeholder Communications Interpersonal Communications Product Lifecycle Management Python (Programming Language) Systems Development Life Cycle Software Development Life Cycle Generative Artificial Intelligence, 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.

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., Statistics Forecasting Excel Macros SAS (Software) Clinical Trials Project Planning Computer Science Applied Mathematics Statistical Analysis Clinical Study Reports Biomedical Engineering Statistical Programming +0 Senior Scientist, Statistical Programming Merck & Co., Inc

North Wales, PA*On-Site

Innovation Statistics Forecasting Excel Macros SAS (Software) Clinical Trials Project Planning Computer Science Applied Mathematics Statistical Analysis Clinical Study Reports Biomedical Engineering Statistical Programming +0 Senior Scientist, Statistical Programming, Late-Stage Oncology (Remote) Merck & Co., Inc

North Wales, PA*Remote

Research Marketing Pipelines Leadership Management Innovation Statistics Compassion SAS Macros Forecasting Decisiveness Life Sciences Biostatistics Data Modeling Collaboration Accountability SAS (Software) Data Integrity Clinical Trials Data Management Project Planning Computer Science Telephone Skills Decision Science Microsoft Project Outcomes Research Shiny (R Package) Project Management Numerical Analysis Applied Mathematics Program Development Reporting Processes Project Stakeholders Statistical Analysis Contingent Workforce Programming Languages Emerging Technologies Electronic Submission Statistical Programming Relationship Management Research And Development Pre-Clinical Development Clinical Data Management R (Programming Language) Stakeholder Requirements Stakeholder Communications Interpersonal Communications Product Lifecycle Management Python (Programming Language) Systems Development Life Cycle Software Development Life Cycle Generative Artificial Intelligence +0 Login | JoinContact

Education and 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

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)
• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

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
• 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:

• Demonstrated experience with advanced programming languages such as R (including Shiny) and/or Python; familiarity with the application of Generative AI and emerging technologies within statistical programming pipelines is highly desirable.
• 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
• Demonstrated proficiency in steering statistical programming deliverables post-DBL, ensuring absolute data integrity of unblinded data.
• Strong capability to operate efficiently in high-pressure environments, swiftly addressing emergent post-DBL challenges through decisive stakeholder communication and rapid technical resolution., Clinical Development, Clinical Trials, Data Management, Data Modeling, Emerging Technologies, Leadership, Numerical Analysis, Outcomes Research, Pressure Management, Project Leadership, Project Management, Project Planning, Stakeholder Relationship Management, Statistical Programming

Preferred Skills: Open Source Technologies, Open Source Tools, Python (Programming Language), R Programming, R Shiny

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.

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.