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Merck · 2 weeks ago

Senior Statistical Programmer- Analysis & Reporting - Hybrid

North Wales, PA

Full-time

Hybrid

Mid, Senior Level

$115K/yr - $180K/yr

3+ years exp

Merck is a global healthcare company that is seeking a Senior Statistical Programmer for their Early Development Statistics team. The role involves providing high-quality statistical programming analysis and reporting deliverables, collaborating with stakeholders to gather user requirements, and developing programming code for regulatory submissions.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

Responsibilities

Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation

Ensure programmatic traceability from data source to analysis/modeling result

Support the development of programming standards to enable efficient and high-quality production of programming deliverables

Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses

Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data

Qualification

SAS programmingClinical trial programmingStatistical methodsData analysisCDISC SDTM/ADaM standardsProgramming algorithmsStakeholder managementPharmaceutical developmentData managementData modelingNumerical analysisClinical pharmacologySoftware development lifecycleInterpersonal skillsWritten communicationPresentation skillsCollaboration

Required

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 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 research and development 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

Experience with at least one other software than SAS (e.g., R, Python, NonMem)

Designs and develops complex programming algorithms

Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages

Experience in CDISC SDTM and ADaM standards

Demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes

Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation

Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters)