Senior Scientist, Statistical Programming - SDTM (Hybrid)

Planning Coaching Research Marketing Templates Consulting Innovation Statistics Compassion Presentations Life Sciences Biostatistics Data Modeling Collaboration Accountability SAS (Software) Clinical Trials Data Management Project Planning Computer Science Telephone Skills Decision Science Microsoft Project Quality Assurance Technical Writing Project Management Quality Management Strategic Thinking Numerical Analysis Process Improvement Applied Mathematics Software Versioning Reporting Processes Project Stakeholders Contingent Workforce Statistical Modeling Electronic Submission Waterfall Methodology Statistical Programming Relationship Management Research And Development Pre-Clinical Development Clinical Data Management R (Programming Language) Stakeholder Requirements Python For Data Analysis Interpersonal Communications Arc Digitized Raster Graphic Python (Programming Language) Continuous Improvement Process Systems Development Life Cycle Software Development Life Cycle Clinical Data Interchange Standards Consortium

At least 5 years $117,000 - $184,200 / yr Posted today, 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 Senior Statistical Programmer, Submission Data Standards Quality Management (SDSQM), 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.

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.

• 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.

Department Required Skills and Experience:

• 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.

Position Specific Required Skills and Experience:

• 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.

Preferred Skills and Experience:

• 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.

eligibleforERP, Clinical Data Interchange Standards Consortium (CDISC) Standards, Data Management, Data Modeling, Numerical Analysis, Stakeholder Relationship Management, Study Data Tabulation Model (SDTM), Waterfall Model

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 primary location for this posting is: USA - Pennsylvania - Upper Gwynedd

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $117,000.00 - $184,200.00

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.