AD, Statistical Programming at Pharmaceutical Company in Cambridge, Massachusetts, United States —
- Pharmaceutical Company
- Cambridge, Massachusetts, United States USA
- 1/11/21 2021-01-11
Job ID: 136859752
· Provides leadership and support to project teams on all statistical/data programming matters according to the projects’ strategies.
· Leads projects for all programming deliverables through the project milestones from study start-up to regulatory submission and approval, and post marketing support.
· Leads and collaborate across functions the identification and development of programming standards and macros to facilitate the creation of statistical deliverables, as well as in process improvement activities to ensure high quality and timely statistical programming deliverables
· Ensures compliance to internal standards and. Work with Data Science management to identify resource needs based on project milestones and deliverables.
· Acts as mentor to junior staff with regard to programming techniques, project management and implementation of standards.
· Contributes to the recruitment process for programmer positions within the department, both contract and permanent.
· Acts as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports.
· Develops data models, programming standards and codes, and training end users in the use of project standards to support programming deliverables that follow regulatory submission requirements.
· Maintains knowledge of new technologies, industry standards, regulatory requirements, and CSO guidelines and SOPs. Implement the quality control procedures that are operationally optimized and in compliance with regulatory requirements.
· Supports department initiatives and task forces. Leads/participates in departmental or cross-functional working groups and process improvement activities.
· Assists in resource assessments based on in-depth project knowledge, milestones and deliverables. Implement global resourcing strategy with regard to the use of off-shore operations, outsourcing and insourcing.
· Effectively interacts with external programming resources, including contributing to development and/or review of contract specifications and feedback on performance.
- MS in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, with 12+ years of programming experience in the pharmaceutical industry; or BS in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, with 15+ years of programming experience in the pharmaceutical industry.
- Advanced SAS programming skills in a clinical data environment with expertise in at least one therapeutic area.
- Knowledge of regulatory requirements concerning electronic submission standards and experience in delivering one or more submissions to regulatory authorities globally.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.