Senior Manager, Statistical Programming

Role Summary

Senior Manager, Statistical Programming responsible for organizing and leading a statistical programming group supporting multiple drug development programs, managing programmers who develop statistical programs, generate analysis datasets, produce outputs for tables and graphs, validate programs, and prepare documentation for electronic submissions.

Responsibilities

• Collaborate with Programming Product lead and project leads in resource planning, allocation and assignment of programmers; ensure adequate staffing of projects.
• Lead or contribute to departmental process and standards initiatives such as macro tools, innovation, CDISC standards implementation.
• Contribute to development and implementation of programming resource algorithms.
• Oversee internal and contract programmers; provide guidance and mentoring in statistical programming methodologies; accountable for career development of all programmers on the team.
• Contribute to selection and management of CROs and outsourcing providers conducting statistical programming.
• Oversee staff supporting clinical trials, ad-hoc analysis requests, data validation, etc., in accordance with relevant statistical regulatory guidance and standards.
• Be a technical resource for the programming group providing advice on complex tasks and standards.
• Provide managerial support for one or more employees with leadership, training, and mentoring responsibilities.
• Participate in development of therapeutic area user guides following CDISC Industry standards.
• Represent statistical programming in cross-functional teams and process improvement initiatives.
• Contribute to department culture and engagement.
• Other duties as assigned.

Qualifications

• Experience leading teams supporting FDA/EMEA/CDE filings.
• Solid knowledge and hands-on experience with CDISC standards (CDASH, SDTM, ADaM).
• Experience leading or working with centralized teams for Statistical Programming.
• Flexible to changing priorities, detail-oriented, able to work under pressure.
• Ability to establish and articulate a plan for a team to ensure focus and direction.
• Ability to accept responsibility for individual and team performance; accountability and ownership.
• Ability to evaluate business impact of decisions and adapt to priority changes.
• Experience in development and implementation of statistical programming standards and procedures.
• Experience with drug development processes (pre-, early, late, or observational) in related industries or academic research; experience with oncology trials.
• Expert level SAS programmer with ability to deliver complex programming tasks; proficient in developing and modifying code.

Skills

• PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
• Knowledge of SDTM and ADaM; ability to write CDISC dataset specifications and create SDTM/ADaM datasets as needed.
• Computer programming using SAS.
• Fundamentals of project planning and management.
• Understanding of the drug development process.

Education

• Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences or related field, or equivalent experience.

Experience

• Minimum 7+ years of clinical research and development programming experience using SAS.
• 2+ years of demonstrated leadership experience.

Additional Requirements

• Regularly required to operate standard office equipment; ability to work on a computer for extended periods; ability to sit for long periods and occasionally stand and walk; ability to use hands to operate equipment; close vision for computer usage; may require lifting up to 20 pounds.