Associate Principal Scientist Statistical Programming, Submission Data Standards Quality Management (Hybrid)

Merck

North Wales (Montgomery County)

On-site

USD 120,000 - 180,000

Full time

39 hours ago

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Job summary

Merck's BARDS department seeks an Associate Principal Statistical Programmer to oversee submission data standards for worldwide regulatory submissions. You will coach teams, coordinate with external vendors, and ensure SDTM/ADaM compliance and data fitness across trials.

The role emphasizes leadership in SDTM/ADaM deliveries, preparation for PreNDA/PreBLA, and engagement with FDA/EMA/PMDA meetings. Collaboration with cross-functional teams is essential for timely deliverables.

Qualifications

BA/BS required with SAS programming experience in a clinical trial environment.
MS preferred with SAS and regulatory submission experience.
Strong knowledge of SDTM/ADaM standards and related deliverables.

Responsibilities

Oversee submission data standard deliverables for regulatory submissions.
Coach project teams and engage with vendors.
Lead continuous improvement of electronic submission processes.
Collaborate with statistics, regulatory and project stakeholders.

Skills

SAS programming

CDISC SDTM/ADaM

Project management

Stakeholder management

Technical writing

Data mapping

Regulatory submissions

Quality assurance

Education

Bachelor's degree 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

Tools

Pinnacle 21 Enterprise

Microsoft Project

Job description

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.

The Associate Principal Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.

The incumbent will be responsible for continuous improvement of our electronic submission process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key collaborator with statistical programming, statistics, regulatory and other project stakeholders and ensures 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.

Primary Activities

PreNDA and PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA).
Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise.
Up-versioning activities to specific versions of SDTM.
Participation in industry teams and conferences on best practices.
Membership on departmental strategic initiative project 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

US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
Strong knowledge and practical experience with CDISC submission standards, including SDTM and ADaM, and associated submission deliverables such as Define-XML, SDRG, and ADRG.
Strong working knowledge of SDTM standards, controlled terminology, and clinical data standardization, including application of standards across clinical studies and development programs.
Experience providing technical guidance and leadership related to SDTM standards, data mapping, implementation, and issue resolution.
Excels in technical writing, able to convert complex ideas and information into simple readable form.
Strong project management and organizational skills, with the ability to manage multiple priorities, deliverables, dependencies, and stakeholders.
Working knowledge of clinical data management and clinical development processes and their relationship to SDTM and downstream submission deliverables
Demonstrated strategic thinking, with the ability to translate strategy into practical standards, processes, and implementation.
Strong stakeholder management and collaboration skills, including the ability to anticipate stakeholder needs, build alignment, and work effectively across functions and geographies.

Preferred Skills And Experience

Experience applying GenAI, automation, and advanced analytics technologies to improve standards development, implementation, and governance.
Experience contributing to or leading Standards governance forums influencing cross‑functional stakeholders and facilitating standards decisions, harmonization, and issue resolution.
Experience with metadata repositories, standards libraries, mapping solutions, or related clinical standards technologies.
Experience with process improvement, automation, and technology‑enabled approaches to improve the efficiency, consistency, traceability, and scalability of standards implementation.
Adaptable and resilient in a dynamic environment, effectively navigating change while quickly integrating into new projects, teams, and stakeholder groups.
Ability and interest to work across cultures and geographies.
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.
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.
Experience in process improvement.