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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Senior Manager - Statistical Programming

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeIn-person

About the Job

Requirements

  • A bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences is required.
  • At least 6 years of programming experience in industry, including support of significant regulatory filings.
  • For U.S. positions, U.S. military experience will be considered toward industry experience.
  • Proficient knowledge of the drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
  • Broad expertise in statistical programming and developing computing strategies.
  • In-depth understanding of clinical data structure, including CDISC standards, and relational databases.
  • Demonstrated proficiency using SAS to produce analysis datasets and tables, listings, and figures, and using other software tools and applications such as Microsoft Office, XML, and Pinnacle 21.
  • Demonstrated ability to process upstream data, including multiple data forms, workflows, electronic data capture, and SDTM, and provide deliverables to meet downstream requirements, including ADaM, tables, listings, and figures, and electronic submission components.
  • Demonstrated ability to work in a team environment with clinical team members.

Responsibilities

  • Provide comprehensive programming leadership and support to clinical project teams and vendors, including deploying programming strategies, standards, specifications, and programmed analyses that comply with regulatory requirements, standard operating procedures, and work practices.
  • Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.
  • Lead or support electronic submission preparation and review.
  • Develop unambiguous and robust programming specifications, such as ADaM specifications.
  • Review key planning documents, including statistical analysis plans, data presentation plans, and data review plans, to align with project objectives and ensure programming assumptions and requirements are clear and complete; assess document robustness and its impact on programming activities.
  • Communicate proactively and effectively about issues and risks and contribute to remediation.
  • Identify, lead, and support opportunities to enhance processes and technology.
  • Lead and support change management, including communication, training, and stakeholder engagement.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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