USA - New Jersey - Rahway, United States of America
Hybrid
Available
Job Description
Statistical Programming is in the Biostatistics and Research Decision Sciences (BARDS) department at our company’s Research & Development Labs which supports the targeting, discovery, development, manufacturing, and marketing of drugs and vaccines for the benefit of patients and global public health.
This position focuses on strategic activities impacting early stage development projects to the direct benefit of project teams and the Biostatistics organization. The principal statistical programmer will partner with statisticians to solve problems; reduce the amount of programming task being completed by statisticians to facilitate an increase in efficiency and compliance for statistical analyses. The incumbent will write programs to analyze data with statistical methods which are not currently available through commercial software packages.
The position is a key collaborator with internal and external stakeholders including Statistics, Clinical Research, Data Management, Regulatory, Clinical Safety, and PK/PD Modeling and Simulation organizations.
Primary Activities:
Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses
Address operational challenges that require strategic solutions across early oncology development
Support the development of programming standards to enable efficient and high quality production of programming deliverables
Facilitate global adoption of standards and programming best practices within the early oncology space
Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data
Lead and actively contribute to departmental strategic initiative project teams
Skills:
Education and Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 12 years SAS/R 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 10 or more years SAS/R 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
Superior knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
Excellent project management skills; leadership across multiple and complex programs; 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
Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) according to quality, compliance and timeliness requirements
Designs and develops complex programming algorithms
Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages.
Thrives in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes
Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation
Experience in CDISC and ADaM standards
Demonstrated success in the assurance of deliverable quality and process compliance
Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions
Ability to anticipate stakeholder requirements
Ability and interest to work across cultures and geographies
Preferred Skills and Experience:
Experience with early oncology development
Experience developing and implementing statistical programming standards
Experience in process assessment, improvement and operational excellence methodologies
Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Experience developing and managing a project plan using Microsoft Project or similar package
Active in professional societies
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
Solid knowledge and experience on oncology clinical trial concepts and standards
#eligibleforERP
BARDS2020
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Required Skills:
Data Management, Datasets, Oncology Trials, Open Source Programming, Project Management, Regulatory SubmissionsPreferred Skills:
PKPD Modeling, Python (Programming Language), R ProgrammingCurrent Employees apply HERE
Current Contingent Workers apply HERE
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:
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
The salary range for this role is
$173,200.00 - $272,600.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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
Search Firm Representatives Please Read Carefully
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.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
07/22/2026*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.
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