Assoc Prin. Scientist Statistical Programming, Late-Stage (Hybrid)

Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's 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. This position supports statistical programming activities for multiple late-stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that 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 through the entire product lifecycle.

Primary Activities:

Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices Maintain and manage a project plan including resource forecasting Coordinate the activities of a global programming team that includes outsource provider staff Membership on departmental strategic initiative teams

Education Requirements:

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 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 a minimum of 7 or more years SAS programming experience in a clinical trial environment

Department Required Skills and Experience:

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

Position Specific Required Skills and Experience:

Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables Designs and develops complex programming algorithms Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards Demonstrated success in the assurance of deliverable quality and process compliance Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices Ability to anticipate stakeholder requirements

Preferred Skills and Experience:

Experience with at least one other software than SAS (e.g., R, Python, NonMem) Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) Experience providing technical and/or programming guidance and mentoring to colleagues 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 #eligiblefor

ERP BARDS2020 SPJOBS VETJOBS

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EBRG Required Skills:

Análisis estadístico, Desarrollo clínico, Ensayos clínicos, Gestión de datos, Gestión de presentaciones, Gestión de proyectos, Modelado de datos, Modelo de tabulación de datos de estudio (SDTM), Normas del Consorcio de Normas de Intercambio de Datos Clínicos (CDISC), Planificación de proyectos, Presentaciones regulatorias, Programación estadística, Programación informática, Programación SAS clínica

Preferred Skills:

Liderazgo, Programación de sistemas de análisis estadístico (SAS), Programación R Current Employees apply HERE Current Contingent Workers apply HERE Solo para residentes en EE. UU. y

Puerto Rico:

Nuestra empresa está comprometida con la inclusión, velando para que las personas puedan participar en un proceso de contratación que muestre sus verdaderas capacidades. Haga clic aquí si necesita adaptaciones durante el proceso de solicitud o contratación. Somos un empleador que ofrece igualdad de oportunidades, comprometido con fomentar un lugar de trabajo inclusivo y diverso. Todos los solicitantes calificados recibirán consideración para el empleo sin distinción de raza, color, edad, religión, sexo, orientación sexual, identidad de género, origen nacional, estado de veterano protegido, o estado de discapacidad, u otras características protegidas legalmente aplicables. Para obtener más información sobre los derechos personales bajo las leyes de empleo de igualdad de oportunidades de los EE. UU., visite: EEOC Conozca sus derechos EEOC Suplemento GINA Transparencia de pago No discriminación Orgullosos de ser una empresa que adopta el valor de reunir a personas diversas, talentosas y comprometidas. La forma más rápida de lograr una innovación revolucionaria es cuando las ideas diversas se unen en un entorno inclusivo. Alentamos a nuestros colegas a desafiar respetuosamente el pensamiento de los demás y abordar los problemas de manera colectiva. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the

San Francisco Fair Chance Ordinance Los 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 Search Firm Representatives Please Read Carefully 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.

Employee Status:

Contrato indefinido

Relocation:

Domestic VISA Sponsorship:

Yes Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid Shift:

Not Indicated Valid Driving License:

No Hazardous Material(s): n/a

Job Posting End Date:

05/1/2026 •A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Nuestra compañía es líder mundial de atención de la salud con una cartera diversificada de medicamentos con receta, vacunas y productos de salud animal. La diferencia entre potencial y logro radica en la chispa que alimenta la innovación y la creatividad; este es el espacio donde hemos codificado nuestro legado durante más de un siglo. Nuestro éxito está respaldado por la integridad ética, el impulso hacia adelante y una misión inspiradora para lograr nuevos hitos en la atención sanitaria global.