Principal Scientist, Stat. Programming - A&R Standards, Innovation (Hybrid)

Socket.dev; North Wales (Montgomery County); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Socket.dev seeks a senior professional to lead clinical trial programming initiatives within BARDS, a Biostatistics and Research Decision Sciences group. The role focuses on scalable analytics, reporting standards, and collaboration across Biostatistics, Data Management, Regulatory, and Clinical Safety teams.

Responsibilities include driving multilingual standards using R, Python, and SAS, with a focus on automation and AI-assisted workflows, while ensuring adherence to SOPs and quality

Qualifications

• BA/BS or MS with 10+ years in clinical trial programming.
• Experience with CDISC SDTM/ADaM and production-quality practices.

Responsibilities

• Drive development and delivery of scalable analysis and reporting standards for drug/vaccine projects across therapeutic areas.
• Collaborate with Biostatistics, Programming, Data Management, Clinical Research, Regulatory and PK/PD teams.
• Lead strategic initiatives and provide technical consultation to statisticians.

Skills

SAS Programming

Data Management

Data Modeling

Numerical Analysis

R Programming

Stakeholder Management

Education

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field

Job description

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 the strategic design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards and tools that can be used for drug and/or vaccine projects across all therapeutic areas. Adheres to standard operating procedures and guidelines established by the department. Drives data structures which include analysis and reporting data standards and submission standards. Actively leads and contributes to the department's strategic initiatives.

The position is a key collaborator with internal and external stakeholders including Biostatistics, Statistical Programming, Data Management, Clinical Research, Regulatory, Observational Research, Clinical Safety, and PK/PD Modeling and Simulation organizations.

Primary Activities

• Drive the development and adoption of scalable, reusable multilingual standards library based on R, Python and SAS with an emphasis on open-source adoption and automation, leveraging AI where appropriate.


• Address operational challenges that require strategic standard-based solutions, resulting in improved analysis and reporting deliverables.


• Facilitate global adoption of standards and programming best practices.


• Contribute to strategic solutions in support of cross functional stakeholder groups in BARDS, GCD, and our Research & Development Division.


• Provide technical consultation and analytical support to statistical programmers and statisticians.


• Lead and actively contribute to departmental strategic initiative project teams.


• Represent our Company on relevant industry initiatives including CDISC and PHUSE.

Skills

Education and Minimum Requirement

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12 or more years statistical programming experience in a clinical trial environment OR


• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years statistical 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 setting strategy and 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

• Expertise in clinical trial programming, including data manipulation, reporting workflows, visualization, and production-quality practices using multiple programming languages and tools.


• 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.


• Strong knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards.


• Experience working with analytical research databases including various analysis datasets and procedures.


• Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development.


• 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 developing flexible and efficient multilingual products for analysis and reporting using R, Python, SAS.


• Experience with process assessment, improvement and operational excellence methodologies.


• Experience developing and managing project plans.


• Experience using AI/GenAI tools, such as Claude Code, to enhance coding, automation and workflow efficiency.


• Active in professional societies and ability to collaborate across regions.

Required Skills: Clinical SAS Programming, Data Management, Data Modeling, Numerical Analysis, R Programming, Stakeholder Relationship Management

Preferred Skills: Python (Programming Language)

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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.

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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 - $272,600.00. This 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

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

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: 09/24/2026

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.