Senior Manager, Statistical Programming (Hybrid)

Avanir Pharmaceuticals

Avanir Pharmaceuticals

North America
Posted on Wednesday, August 2, 2023

The Senior Manager, Statistical Programming leads and participates in the development and validation of datasets, tables, listings, and figures (TLFs) that support the analysis and reporting of clinical trials and for providing expertise for statistical programming activities. You will develop collaborative relationships and work within the Statistical Programming team, with cross-functional teams, and external vendors.

Job Description

  • Create SAS programs to produce derived analysis datasets and content for TLFs.
  • Perform programming validation to ensure quality of analysis datasets and programming outputs.
  • Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis.
  • Lead submission preparations, deliverables, and regulatory responses.
  • Review important planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure understanding of development team goals and clarity and completeness of programming assumptions and requirements; assess impact on programming activities.
  • Work with vendors regarding project standards, programming conventions, programming specifications and file transfers.
  • Provide leadership for ensuring quality of deliverables by applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and working practices.
  • Identify opportunities for increased efficiency and consistency within Statistical Programming, Clinical Analytics, and interactions with vendors.
  • Independently lead programming assignments.
  • Lead process improvement and standards and automation projects.

Required Knowledge/ Experience:

  • Demonstrated proficiency in using SAS, R, or other programming languages to produce derived analysis datasets and TFLs.
  • Knowledge of CDISC standards and relational database structures.
  • Experience using software tools and applications, e.g., MS office, XML, Pinnacle 21.
  • Provide outputs to meet submission requirements such as ADaM datasets, define files and reviewer’s guides, etc.
  • Knowledge of regulatory, industry, and technology standards.
  • Knowledge of the drug development process, clinical trials, medical terminology, statistical analysis plans and protocol designs.
  • Work in a team environment with clinical team members.

Educational Qualifications

  • Bachelor's degree (Master's Degree preferred) in Computer Science or Computer Science Engineering or equivalent field.



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Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

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This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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