{"id":4054522,"url":"https://alion.io/job/merck-co-senior-scientist-statistical-programming-sdtm-hybrid","title":"Senior Scientist, Statistical Programming - SDTM (Hybrid)","company":{"id":3768,"name":"Merck & Co.","domain":"msd.com","url":"https://alion.io/company/msd","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":97,"open_postings":212,"ghost_share":0.028,"stale_share":0.146,"repost_share":0.203,"time_to_fill_p50_days":16,"computed_at":"2026-11-11T05:49:22Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["North Wales, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":117000,"max":184200,"currency":"USD","period":"year","gross":null,"usd_annual":184200},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CDISC","optional":false},{"name":"SAS","optional":false},{"name":"Microsoft Project","optional":true},{"name":"Python","optional":true},{"name":"Waterfall","optional":true}],"status":"live","first_seen_at":"2026-11-10T00:00:00Z","employer_posted_date":"2026-11-10","last_verified_at":"2026-11-11T03:56:37Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Job Description\nIn 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.\nResponsibilities:\nThe 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.\nThe 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.\nPrimary Activities:\nPreNDA 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).\nGuiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise.\nUp-versioning activities to specific versions of SDTM.\nParticipation in industry teams and conferences on best practices.\nMembership on departmental strategic initiative project teams.\nEducation and Minimum Requirement:\nBA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment.\nMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment.\nDepartment Required Skills and Experience:\nEffective interpersonal skills and ability to negotiate and collaborate effectively.\nEffective written, oral, and presentation skills.\nEffective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).\nA project leader; completes tasks independently at a project level; ability to collaborate with key stakeholder.\nPosition Specific Required Skills and Experience:\nUS and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.\nExperience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG.\nDemonstrated success in the assurance of deliverable quality and process compliance.\nExcels in technical writing, able to convert complex ideas and information into simple readable form.\nSolid project management skills.\nFamiliarity with clinical data management concepts.\nStrategic thinking - ability to turn strategy into tactical activities.\nAbility to anticipate stakeholder requirements.\nPreferred Skills and Experience:\nHands-on experience with R and Python for data analysis and statistical modeling.\nStrong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC).\nExperience assuring consistency across protocols and projects.\nAbility and interest to work across cultures and geographies.\nAbility to complete statistical programming deliverables through the use of global outsource partner programming staff.\nExperience developing and managing a project plan using Microsoft Project or similar package.\nActive in professional societies.\nExperience in process improvement.\neligibleforERP\nSPjobs\nBARDS2020\nVETJOBS\nEBRG\nRequired Skills:\nClinical Data Interchange Standards Consortium (CDISC) Standards, Data Management, Data Modeling, Numerical Analysis, Stakeholder Relationship Management, Study Data Tabulation Model (SDTM), Waterfall ModelPreferred Skills:\nPython (Programming Language), R ProgrammingCurrent Employees apply HERE\nCurrent Contingent Workers apply HERE\nUS and Puerto Rico Residents Only:\nOur 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.\nAs 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. Asa 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:\nEEOC Know Your Rights\nEEOC GINA Supplement\nWe 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.\nLearn more about your rights, including under California, Colorado and other US State Acts\nThe primary location for this posting is:\nUSA - Pennsylvania - Upper GwyneddWhere required by law, the compensation range for this role is provided below.\nThe salary range for the primary location of this role is:\n$117,000.00 - $184,200.00This 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.\nWe 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.\nAdditional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.\nAdditional location(s) Compensation Information:\nSan Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance\nLos 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\nSearch Firm Representatives Please Read Carefully\nMerck & 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.\nEmployee Status:\nRegularRelocation:\nDomesticVISA Sponsorship:\nNoTravel Requirements:\n10%Flexible Work Arrangements:\nHybridShift:\nNot IndicatedValid Driving License:\nNoHazardous Material(s):\nn/aJob Posting End Date:\n11/30/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. 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