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

Merck

USA - Pennsylvania - North Wales (Upper Gwynedd); USA - New Jersey - RahwayPosted 12 days agoDiscoveredMatch locked

HybridFull time7+ years exp

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.

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

Current 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: EEOC Know Your Rights EEOC GINA Supplement 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 $142,400.00 - $224,100.00 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 . 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

Regular

Relocation

Domestic

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

Hazardous Material(s)

n/a

Job Posting End Date

10/13/2026 *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.

Not included in the source posting: about the role, what you'll do, benefits.

Skills

generative-ai

Who can apply

The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.

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