Senior Scientist, Statistical Programming - SDTM (Hybrid)

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.

• →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.

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment.
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 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 stakeholder.

• US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
• Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, 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.
• Solid project management skills.
• Familiarity with clinical data management concepts.
• Strategic thinking - ability to turn strategy into tactical activities.
• Ability to anticipate stakeholder requirements.

• Hands-on experience with R and Python for data analysis and statistical modeling.
• 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.
• 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.

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This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.