Senior Statistical Programmer - Early Oncology Development

Merck & Co.

Rahway (NJ)

Hybrid

USD 173,200 - 272,600

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co. in Rahway, NJ is seeking a Principal Statistical Programmer to partner with statisticians, develop analysis and reporting deliverables, and lead strategic programming initiatives in early oncology development.

The role focuses on solving problems, improving efficiency and compliance for complex analyses, and pre-processing large biomarker and imaging datasets. Requires extensive SAS/R programming in a clinical trial setting with CDISC/ADaM experience.

Qualifications

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 12 years SAS/R programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 10 or more years SAS/R programming experience in a clinical trial environment
Excellent interpersonal skills and ability to negotiate and collaborate effectively
Excellent written, oral, and presentation skills
Superior knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics)
Excellent project management skills; leadership across multiple and complex programs; 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
Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) according to quality, compliance and timeliness requirements
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.
Thrives 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
Experience in CDISC and ADaM standards
Demonstrated success in the assurance of deliverable quality and process compliance
Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions
Ability to anticipate stakeholder requirements
Ability and interest to work across cultures and geographies
Experience with early oncology development
Experience developing and implementing statistical programming standards
Experience in process assessment, improvement and operational excellence methodologies
Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Experience developing and managing a project plan using Microsoft Project or similar package
Active in professional societies
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
Solid knowledge and experience on oncology clinical trial concepts and standards

Responsibilities

Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses
Address operational challenges that require strategic solutions across early oncology development
Support the development of programming standards to enable efficient and high quality production of programming deliverables
Facilitate global adoption of standards and programming best practices within the early oncology space
Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data
Lead and actively contribute to departmental strategic initiative project teams