Responsibilities
- Direct and manage statistical programming activities for clinical trials.
- Ensure data integrity and compliance with regulatory standards.
- Develop and implement statistical programming standards and procedures.
- Collaborate with cross-functional teams to ensure timely and accurate delivery of statistical programming outputs.
- Provide technical expertise and guidance to statistical programming team members.
- Review and approve statistical programming deliverables.
- Participate in the development and review of statistical analysis plans.
- Contribute to the development and maintenance of statistical programming documentation.
- Identify and implement process improvements to enhance efficiency and quality.
- Stay current with industry trends and regulatory requirements.
- Provide input into the development of statistical programming budgets and resource plans.
- Participate in the development and review of statistical programming training materials.
- Provide mentorship and training to junior statistical programmers.
- Ensure adherence to project timelines and milestones.
- Collaborate with vendors and external partners as needed.
- Participate in the development and review of statistical programming validation plans.
- Provide input into the development of statistical programming quality assurance plans.
- Participate in the development and review of statistical programming risk management plans.
- Collaborate with clinical operations to ensure alignment with project objectives.
- Participate in the development and review of statistical programming project plans.
- Provide input into the development of statistical programming resource allocation plans.
- Participate in the development and review of statistical programming project status reports.
Nice to Have
- Master's degree in a relevant field, such as statistics, biostatistics, or a related discipline.
- Certification in statistical programming or a related field.
- Experience in leading and managing large, complex statistical programming projects.
- Experience in working with global teams.
- Experience in using statistical programming software, such as R or Python.
- Experience in working with electronic data capture (EDC) systems.
- Experience in working with clinical trial management systems (CTMS).
Compensation
Competitive
Work Arrangement
Hybrid
Team
Reporting to the Director of Statistical Programming, you will lead a team of statistical programmers and collaborate with cross-functional teams, including data management, biostatistics, and clinical operations.
What We Offer
- A competitive salary and benefits package.
- Opportunities for professional development and growth.
- A collaborative and supportive work environment.
- The chance to work on innovative and impactful projects.
- A commitment to work-life balance.
Our Values
- Integrity: We act with honesty and transparency in all our actions.
- Innovation: We foster a culture of continuous improvement and innovation.
- Collaboration: We work together to achieve our shared goals.
- Excellence: We strive for excellence in everything we do.
- Respect: We treat everyone with respect and dignity.
Our Culture
- We value diversity and inclusion, and we strive to create a welcoming and inclusive work environment for all employees.
- We encourage open communication and feedback, and we value the input of all team members.
- We support work-life balance and offer flexible work arrangements to help employees balance their work and personal lives.
- We provide opportunities for professional development and growth, and we support employees in achieving their career goals.
- We foster a culture of continuous learning and improvement, and we encourage employees to stay current with industry trends and best practices.
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