PRINCIPAL STATISTICAL PROGRAMMER, LATE STAGE DEVELOPMENT - ONCOLOGY
August 9, 2018
Upper Gwynedd, Pennsylvania
Full Time - Experienced
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
This position focuses on multiple indications and external collaboration efforts in Late stage Oncology group including filing activities and developing strategic solutions to the direct benefit of project teams and the Biostatistics organization.
The position is a key collaborator with internal and external stakeholders including Data Management, Statistics, Clinical Research and Regulatory organizations.
Address operational challenges that require strategic solutions, resulting in improved CSR and filing completion timelines worldwide
Lead Oncology Submissions, address US/ex-US agency questions and mentor other programmers across Oncology Franchise
Facilitate global adoption of TA standards and programming best practices
Contribute to defining solutions for bringing external studies in-house to meet submission timelines
Mentor other programmers on life cycle of drug development in Oncology Franchise
Lead and actively contribute to departmental strategic initiative project teams
Contribute/Participate on external committees (e.g. ADAM, PhUSE, CDSIC –Oncology etc.) to align operational requirements for Oncology Franchise
Education Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12-15 years SAS programming experience in a clinical trial environment
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years SAS programming experience in a clinical trial environment
Required Experience and Skills:
Department Required Skills and Experience:
Excellent interpersonal skills and ability to negotiate and collaborate effectively
Excellent written, oral, and presentation skills
Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs effort others; ability to engage key stakeholders
Position Specific Required Skills and Experience:
Expertise in SAS and clinical trial programming (Safety and Efficacy)
Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements
US and/or worldwide Oncology regulatory application submission experience at the leadership level including the development of electronic submission deliverables
Designs and develops complex programming algorithms in Oncology area
Familiarity with statistical analysis methods, terminology and concepts
Familiarity with clinical data management concepts
Experience in CDISC ,SDTM 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
Ability to manage multiple study deliverables at a time
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.