Associate Principal Scientist, Stat. Programming - SDTM (Hybrid)

Merck • North Wales, PA

21d • Hybrid

About The Position

Associate Principal Statistical Programmer, Submission Data Standards Quality Management
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.
Responsibilities:
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.

Requirements

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 or more years SAS programming experience in a clinical trial environment.
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment.
• 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
• US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level, including the development of electronic submission deliverables.
• Experience with submission standards CDISC (SDTM, ADaM), Define.XML, SDRG, ADRG.
• Demonstrated success in the assurance of deliverable quality and process compliance.
• Excels in technical writing, able to convert complex ideas and information into simple readable form.
• Strong Technical Knowledge with experience in Python and SAS.
• Strong project management skills.
• Familiarity with clinical data management concepts.
• Strategic thinking - ability to turn strategy into tactical activities.
• Ability to anticipate stakeholder requirements.

Nice To Haves

• Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC).
• Experience providing technical and/or programming guidance and mentoring to colleagues.
• Deals well with change and seamlessly assimilates to new projects and stakeholders.
• 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.

Responsibilities

• 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.
• Develop SAS Macros and Python Functions and Derivations for SDTM Conversions.
• Participation in industry teams and conferences on best practices.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees