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Merck · 2 hours ago

Associate Principal Scientist Statistical Programming - Late-Stage (Non-Oncology) (Hybrid)

USA - Pennsylvania - North Wales (Upper Gwynedd)

Full-time

Hybrid

Senior Level, Lead/Staff

$142K/yr - $224K/yr

7+ years exp

Merck is a leading pharmaceutical company dedicated to improving global health. They are seeking an Associate Principal Scientist to support statistical programming activities for late-stage drug and vaccine clinical development projects, ensuring high-quality deliverables and effective collaboration with project stakeholders.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

Responsibilities

Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures) for clinical trials and regulatory submissions

Design and maintenance of statistical databases that support multiple stakeholder groups

Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle

Assure deliverable quality and process compliance

Develop deliverables utilizing global and TA standards that optimize analysis and reporting

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 project teams such as new statistical computing platform evaluation and development

Qualification

SAS programmingStatistical analysisStatistical programmingProject managementClinical trial experienceCDISC standardsData managementStakeholder engagementInnovationProcess improvementsCommunication skillsTeamwork

Required

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment

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

Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team

Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements

Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts

US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables

Strong project management skills; A program leader; Determines appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders

Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts Designs and develops complex programming algorithms

Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders

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

Experience in CDISC and ADaM standards

Demonstrated success in the assurance of deliverable quality and process compliance

Ability to anticipate stakeholder and regulatory requirements