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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Manager Statistical Programming

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeWarsaw, PolandIn-person

About the Job

Requirements

  • A bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences is required.
  • At least 4 years of programming experience in industry.
  • Demonstrated proficiency using SAS, R, or other programming languages to produce derived analysis datasets and tables, listings, and figures.
  • In-depth understanding of clinical data structures, including CDISC standards, and relational databases.
  • Demonstrated skills using software tools and applications such as Microsoft Office, XML, and Pinnacle 21.
  • Demonstrated ability to handle and process upstream data, including multiple data forms, workflows, electronic data capture, and Study Data Tabulation Model (SDTM).
  • Demonstrated ability to provide outputs that meet downstream requirements, including Analysis Data Model (ADaM), Data Definition Tables, and electronic submissions.
  • Good understanding of regulatory, industry, and technology standards and requirements.
  • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
  • Demonstrated ability to work in a team environment with clinical team members.

Responsibilities

  • Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures, and perform programming validation to ensure the quality of analysis datasets and programming outputs.
  • Provide comprehensive programming support for project teams, including developing programming strategies, standards, specifications, and programmed analyses.
  • Support electronic submission preparation and review.
  • Review key planning documents, including statistical analysis plans, data presentation plans, and data review plans, to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; assess impacts on programming activities.
  • Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers.
  • Provide leadership to ensure the quality of Global Biometrics & Data Sciences deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental standard operating procedures and work practices.
  • Identify opportunities for increased efficiency and consistency within Global Biometrics & Data Sciences and in interactions with strategic vendors.
  • Independently lead and/or perform programming assignments across multiple projects with minimal supervision.
  • Support improvement initiatives.

Desired Qualifications

  • At least 4 years of clinical or statistical programming experience within pharmaceutical clinical development, including supporting regulatory filings such as New Drug Applications, Biologics License Applications, or Marketing Authorization Applications.
  • Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements.
  • Experience with other software packages, such as R.
  • Experience with the Linux operating system.

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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