Ccrps
Associate Principal Scientist, Statistical Programmer | Oncology (Hybrid)
Ccrps, Rahway, New Jersey, us, 07065
Job Description
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our 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 multiple and/or 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), ranging from individual clinical trials to worldwide regulatory application submissions and post‑marketing support.
The incumbent designs and maintains statistical datasets that support multiple stakeholder groups, including clinical development, outcomes research, and safety evaluation. The role is a key collaborator with statistics and other project stakeholders to ensure that project plans are executed efficiently with timely, high‑quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder throughout the product lifecycle.
Primary Activities
Effective analysis and report programming development and validation utilizing global and therapeutic area 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 Requirements
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment.
MS in the same fields plus 7 or more years SAS programming experience in a clinical trial environment.
Department Required Skills and Experience
Excellent interpersonal skills and ability to negotiate and collaborate effectively.
Excellent written, oral, and presentation skills.
Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage 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.
Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
Designs and develops complex programming algorithms.
Ability to comprehend analysis plans that describe methodology to be programmed, an understanding of statistical terminology and concepts.
Familiarity with clinical data management concepts.
Experience in CDISC and ADaM standards.
Demonstrated success in ensuring deliverable quality and process compliance.
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
Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC).
Experience providing technical and/or programming guidance and mentoring to colleagues.
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.
Salary range: $135,500.00 – $213,400.00. The successful candidate will be eligible for annual bonus and long‑term incentive if applicable.
We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.
Application deadline is until 01/26/2026. Apply at https://jobs.merck.com/us/en.
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.
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This position supports statistical programming activities for multiple and/or 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), ranging from individual clinical trials to worldwide regulatory application submissions and post‑marketing support.
The incumbent designs and maintains statistical datasets that support multiple stakeholder groups, including clinical development, outcomes research, and safety evaluation. The role is a key collaborator with statistics and other project stakeholders to ensure that project plans are executed efficiently with timely, high‑quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder throughout the product lifecycle.
Primary Activities
Effective analysis and report programming development and validation utilizing global and therapeutic area 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 Requirements
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment.
MS in the same fields plus 7 or more years SAS programming experience in a clinical trial environment.
Department Required Skills and Experience
Excellent interpersonal skills and ability to negotiate and collaborate effectively.
Excellent written, oral, and presentation skills.
Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage 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.
Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
Designs and develops complex programming algorithms.
Ability to comprehend analysis plans that describe methodology to be programmed, an understanding of statistical terminology and concepts.
Familiarity with clinical data management concepts.
Experience in CDISC and ADaM standards.
Demonstrated success in ensuring deliverable quality and process compliance.
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
Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC).
Experience providing technical and/or programming guidance and mentoring to colleagues.
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.
Salary range: $135,500.00 – $213,400.00. The successful candidate will be eligible for annual bonus and long‑term incentive if applicable.
We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.
Application deadline is until 01/26/2026. Apply at https://jobs.merck.com/us/en.
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.
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