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Merck · 9 hours ago

Associate Principal Scientist, Statistical Programmer | Oncology (Hybrid)

North Wales, PA

Full-time

Hybrid

Senior Level, Lead/Staff

$136K/yr - $213K/yr

7+ years exp

Merck is a renowned company in the field of healthcare, focusing on the discovery and development of medical drugs and vaccines. The Associate Principal Scientist, Statistical Programmer position is responsible for supporting statistical programming activities for late-stage drug/vaccine clinical development projects, ensuring high-quality deliverables and collaboration with various stakeholders.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

Responsibilities

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

Qualification

SAS programmingStatistical analysisClinical trial programmingProject managementCDISC standardsADaM standardsStatistical terminologyProcess improvementInterpersonal skillsWritten communicationPresentation skillsStrategic thinkingMentoringCollaborationLeadership

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

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

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