Merck · 20 hours ago
Sr. Scientist, Statistical Programmer, Submission Data Standards Quality Management (Hybrid)
North Wales, PA
Full-time
Hybrid
Mid, Senior Level
$117K/yr - $184K/yr
3+ years expMerck is a renowned company in the field of Research and Development, focusing on medical drugs and vaccines. They are seeking a Senior Statistical Programmer to provide oversight and quality management of submission data standards for regulatory applications in drug and vaccine clinical development projects.
BiotechnologyHealth CareMedicalPharmaceutical
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
Participation in industry teams and conferences on best practices
Membership on departmental strategic initiative project teams
Qualification
Required
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment
Effective interpersonal skills and ability to negotiate and collaborate effectively
Effective written, oral, and presentation skills
Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
A project leader; completes tasks independently at a project level; Ability to collaborate with key stakeholders
US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
In-depth knowledge of and direct experience implementing industry clinical data standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (e.g., SDRG, ADRG, Define.xml)
Proficiency in diverse data collection methods, including eCRF, IRT, and central lab data
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
Solid project management skills
Strategic thinking - ability to turn strategy into tactical activities
Ability to anticipate stakeholder requirements
Preferred
Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Experience assuring consistency across protocols and projects
Ability and interest to work across cultures and geographies
Knowledge of clinical data metadata & information management platforms and systems
Experience using SAS, R, and Python to generate data-driven insights
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
Experience developing and managing a project plans in Microsoft Project or similar tools
Active participation in professional societies
Experience leading or contributing to process improvement initiatives
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
2026-01-23
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