Hispanic Alliance for Career Enhancement
Sr. Scientist, Statistical Programmer, Late Stage Development Oncology- Hybrid
Hispanic Alliance for Career Enhancement, North Wales, Pennsylvania, United States
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.
Responsibilities 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
Skills and Qualifications Education and Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 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 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
Eligible for ERP
Bards2020
SPjobs
VETJOB
EBRG
Current Employees apply HERE
Current Contingent Workers apply HERE
EEO and Policies 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.
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
Work Model and Benefits U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work arrangement consisting of three total days on-site per week, Monday - Thursday, with Friday remote, unless business critical tasks require on-site presence. This model does not apply to field-based positions, facility/manufacturing/research roles, positions covered by a collective-bargaining agreement, or any role where remote work is not feasible.
The salary range for this role is $114,700.00 - $180,500.00. Final compensation is based on factors including education, experience, location, and business needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive benefits package. More information is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en. The application deadline is stated on this posting.
Notes:
San Francisco residents only, Los Angeles residents only, and search firm policies apply as described in the posting.
Job Posting End Date: 11/28/2025. Requisition ID: R364171
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Responsibilities 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
Skills and Qualifications Education and Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 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 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
Eligible for ERP
Bards2020
SPjobs
VETJOB
EBRG
Current Employees apply HERE
Current Contingent Workers apply HERE
EEO and Policies 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.
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
Work Model and Benefits U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work arrangement consisting of three total days on-site per week, Monday - Thursday, with Friday remote, unless business critical tasks require on-site presence. This model does not apply to field-based positions, facility/manufacturing/research roles, positions covered by a collective-bargaining agreement, or any role where remote work is not feasible.
The salary range for this role is $114,700.00 - $180,500.00. Final compensation is based on factors including education, experience, location, and business needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive benefits package. More information is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en. The application deadline is stated on this posting.
Notes:
San Francisco residents only, Los Angeles residents only, and search firm policies apply as described in the posting.
Job Posting End Date: 11/28/2025. Requisition ID: R364171
#J-18808-Ljbffr