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Merck

Makes medicines, vaccines and animal treatments

Associate Principal Scientist - Statistical Programming

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeRahway, NJ, USA

About the Job

Requirements

  • A bachelor's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceuticals, or a closely related field and 9 years of experience in the position offered or a related role; alternatively, a master's degree or equivalent in those fields and 7 years of experience.
  • Seven years of experience with SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, and SAS/GRAPH.
  • Seven years of experience leading large or complex statistical programming projects that include coordinating a programming team.
  • Seven years of experience designing and developing complex programming algorithms.
  • Seven years of experience with clinical data management concepts and data management systems and processes.
  • Seven years of experience with CDISC and ADaM standards.
  • Seven years of experience assuring deliverable quality and process compliance.
  • Seven years of experience turning strategy into tactical activities and anticipating stakeholder requirements.
  • Seven years of leadership-level experience with U.S. and/or worldwide drug or vaccine regulatory application submissions, including developing electronic submission deliverables.
  • Seven years of experience comprehending analysis plans that describe methodology to be programmed.
  • Seven years of experience with statistical terminology, models, and concepts.
  • Seven years of experience designing statistical databases to optimize analysis and reporting and leverage departmental standards and industry best practices.

Responsibilities

  • Support statistical programming activities for multiple and/or late-stage drug or vaccine clinical development projects.
  • Develop and execute statistical analysis and report deliverables, including safety and efficacy analysis datasets, tables, listings, and figures, spanning individual clinical trials, worldwide regulatory application submissions, and post-marketing support.
  • Design and maintain statistical datasets that support clinical development, outcomes research, and safety evaluation stakeholder groups.
  • Collaborate with statistics and other project stakeholders to ensure project plans are executed efficiently and deliverables are timely and high quality.
  • Serve as the statistical programming point of contact and knowledge holder throughout the project life cycle.
  • Analyze and report programming development and validation using global and therapeutic-area standards and following departmental standard operating procedures and good programming practices.
  • Maintain and manage a project plan, including resource forecasting.
  • Coordinate activities of a global programming team, including outsourced provider staff.
  • Participate in departmental strategic initiative teams.
  • Travel domestically 10% of the time.

About the Company

Merck

Makes medicines, vaccines and animal treatments

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Rahway, NJ
Founded
1891

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