MSD

Associate Principal Scientist, Statistical Programmer – Oncology

MSD

full-time

Posted on:

Location Type: Hybrid

Location: North Wales • New Jersey, Pennsylvania • 🇺🇸 United States

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Salary

💰 $135,500 - $213,400 per year

Job Level

JuniorMid-Level

About the role

  • Support statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects.
  • Develop and execute statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures) from individual trials to worldwide regulatory application submissions and post-marketing support.
  • Design and maintain statistical datasets supporting clinical development, outcomes research and safety evaluation.
  • Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle for assigned projects.
  • Maintain and manage project plans including resource forecasting; coordinate activities of global programming teams and outsource provider staff.
  • Develop, validate, and ensure quality of analysis and report programming utilizing global and TA standards, departmental SOPs and good programming practices.
  • Provide leadership at a program level, direct development of others, engage stakeholders, and participate on departmental strategic initiative teams.
  • Ensure deliverable quality, process compliance, and regulatory submission readiness.

Requirements

  • 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.
  • 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 and coordinating global programming teams including outsource provider staff.
  • US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including development of electronic submission deliverables.
  • Familiarity with clinical data management concepts.
  • Experience in CDISC and ADaM standards.
  • Strong project management skills; leadership at a program level; experience using Microsoft Project or similar.
  • Excellent interpersonal, written, oral, and presentation skills.
  • Demonstrated success in assurance of deliverable quality and process compliance.
  • Ability to design and develop complex programming algorithms.
  • VISA Sponsorship: Yes (employer indicates sponsorship is available).
Benefits
  • Eligible for annual bonus and long-term incentive
  • Medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • Retirement benefits, including 401(k)
  • Paid holidays, vacation, and compassionate and sick days
  • Comprehensive package of benefits
  • Relocation: Domestic
  • VISA Sponsorship: Yes
  • Flexible Work Arrangements: Hybrid
  • U.S. Hybrid Work Model: three total days on-site per week (Mon-Thu) with Friday designated as a remote-working day

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
SAS programmingstatistical analysisdata stepsproceduresSAS/MACROSAS/GRAPHprogramming algorithmsclinical trial programmingCDISC standardsADaM standards
Soft skills
project managementleadershipinterpersonal skillswritten communicationoral communicationpresentation skillsstakeholder engagementteam coordinationprocess compliancequality assurance