Merck & Co, Inc

Assoc Principal Scientist Statistical Programming, Late-Stage (Non-Oncology) (Hybrid)

Merck & Co, Inc • $142K — $224K *
North Wales, PA 19454Hybrid
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BA/BS in Computer Science, Statistics, Life Sciences, or related field with 9+ years of SAS programming experience, or MS with 7+ years of SAS programming experience in a clinical trial environment.
  • Significant expertise in SAS including MACRO and GRAPH procedures.
  • Experience leading large statistical programming projects and coordinating teams.
  • Knowledge of CDISC and ADaM standards.
  • Strong interpersonal and project management skills.

Responsibilities

  • Lead statistical programming activities for clinical development projects.
  • Develop and validate programming for safety and efficacy analysis datasets.
  • Manage project plans and resource forecasting effectively.
  • Collaborate with global programming teams and external partners.
  • Serve as a key contact for statistical programming throughout the product lifecycle.

Benefits

  • Relocation assistance available.
  • Visa sponsorship offered.
  • Flexible hybrid work arrangements.
  • Ability to work across diverse cultures and geographic locations.
  • Opportunities for process improvement and professional development.
Full Job Description
Job Description

This position leads 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), 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
  • 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:
  • 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 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
  • Demonstrated success in the assurance of 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 with GenAI tools (e.g., Python, R, R Shiny, Claude, etc.)
  • 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


BARDS2020

eligibleforERP

SPjobs

VETJOBS

EBRG

Required Skills:
CDISC ADaM, Clinical Data Interchange Standards Consortium (CDISC) Standards, Project Management, Regulatory Submissions, Stakeholder Relationship Management, Statistical Analysis Systems (SAS) Programming

Preferred Skills:
Generative AI, Python (Programming Language), R Programming

Current Employees apply HERE

Current Contingent Workers apply HERE

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:
09/25/2026
*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.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

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Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

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At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

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We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

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Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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