Associate Principal Scientist Statistical Programming, Submission Data Standards Quality Management

Regulatory Jobs; North Wales (Montgomery County); On-site; USD 140,000 - 190,000; Full time

Job summary

BARDS in the R&D division seeks an Associate Principal Statistical Programmer to oversee submission data standards for global regulatory submissions. You will coach teams, liaise with vendors, and stay current with SDTM/ADaM and CDISC standards while improving electronic submission processes.

You will serve as the statistical programming point of contact on assigned projects, ensuring traceability, quality assurance, data conformance and timely deliverables in a collaborative environment across

Qualifications

• Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Strong writing skills and ability to translate complex ideas into readable form.
• Experience with SDTM and ADaM data standards and related submission deliverables (Define-XML, SDRG, ADRG).

Responsibilities

• PreNDA and PreBLA meeting preparation; study data standards plan; prepare FDA e-data questions.
• Guide project teams on submission deliverables including Pinnacle 21 Enterprise usage.
• Up-versioning activities to specific versions of SDTM.
• Collaborate with regulatory, statistics and programming teams to ensure timely, high-quality deliverables.

Skills

Interpersonal skills

Written/oral/presentation skills

R&D analytics

Project management

Leadership at program level

Stakeholder management

SAS programming

SDTM/ADaM knowledge

CDISC standards

Statistical programming

Global coordination

Outsourcing partner management

SAS programming in clinical trials

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

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.

BARDS2020

eligibleforERP

SPjobs

VETJOBS

EBRG

Required Skills:

Business Process Creation, Business Process Improvements, Business Writing, Change Management, Data Management, Data Modeling, Global Coordination, Influencing Skills, Numerical Analysis, Partner Relationship Management (PRM), Presentation Delivery, Process Implementations, Project Integration, Project Leadership, Project Management Leadership, Stakeholder Management, Stakeholder Relationship Management, Standards Compliance, Standards Development, Statistical Programming, Strategic Planning, Strategic Thinking, Strategy Development, Waterfall Model

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.

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 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

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