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Merck · 2 weeks ago

Sr. Scientist, Statistical Programmer, Late Stage Development Oncology- Hybrid

North Wales, PA

Full-time

Hybrid

Mid, Senior Level

$115K/yr - $180K/yr

5+ years exp

Merck is a leading company in the pharmaceutical industry, seeking a Sr. Scientist in Statistical Programming to support late stage drug and vaccine clinical development projects. The role involves leading statistical analysis and reporting deliverables, ensuring high quality and timely execution throughout the product lifecycle.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

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 programmingCDISC ADaMDatabase managementProject managementStakeholder managementInterpersonal skillsPresentation skillsNegotiation skills

Required

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

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 stakeholders

Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise

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

Experience ensuring process compliance and deliverable quality

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

Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)

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

Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor

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