As an Associate Director/Director and Programming Team Lead (PTL) within the Oncology Programming department you will lead, direct and line manage a team of programmers along with the programming work required to deliver the requirements of a drug project(s). You will work collaboratively with both biometrics drug project team leaders and members along with cross functional teams. You will be an integral part of the Oncology Programming department that oversees and delivers the programming aspects of clinical development, manages and maintains our end-to-end standards and our analysis and reporting production tools. You will provide support for regulatory submissions including development of the submission strategy, delivering according to that strategy (CSR/HLD databases and outputs) and responses to regulatory questions.
Ultimately, the Oncology Programming department oversees and delivers all of the programming contribution to internal decision making, regulatory submissions and reporting and commercial activities for the portfolio of drug projects within the Oncology R&D organisation.
If you're inspired by the possibilities of science to make a difference and ready to discover what you can do - join us.
Main Duties and Responsibilities
Reporting to a Senior Director within the Oncology Programming department you will act as the strategic programming leader providing support for all aspects of the clinical development process including, but not limited to, clinical development plans, regulatory submissions, programming and information deliverables, commercialization and scientific utilization data for oncology products
You will lead the provision of technical expertise to external partners in relation to the specification and delivery of the SDTM/ADaM databases and outputs by these partners. This will include overseeing the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable.
In this role, you will have accountability for the quality of a drug project(s) programming work worldwide. You will also work to improve quality, efficiency and effectiveness by contributing to the development of best practice and identifying opportunities to improve our processes by providing practical solutions to problems.
- BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science
- Extensive SAS programming expertise to an advanced level
- Comprehensive knowledge of technical and regulatory requirements related to the role
- Knowledge of CDSIC standards and industry best practices
- Extensive experience in clinical drug development or healthcare
- Experience in Regulatory submissions
- Excellent verbal and written communication skills and influence stakeholders
- Lead the development and delivery of training
- Advanced to expert verbal and written communication and collaboration skills.
- Advanced to expert problem solving and conflict resolution.
- Drive others to work across global & functional boundaries.
- Travel - willingness and ability to travel domestically and/or internationally.
- Ability to apply programming knowledge and skills to problems, problem solving, and quality focus. Troubleshoots for team.
- Contributes to defining business processes and accurately completes and manages associated documentation.
- Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
- Diligence - attention to detail and ability to manage concurrent projects and activities within those projects.
- Other programming languages e.g. S-PLUS, R, XML etc.
- Extensive knowledge of Pinnacle 21 Validator
The level of the position will be determined by the candidate's experience, skills and abilities.