Lead, Statistical Programming

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Requirements:

• Bachelor’s Degree in Mathematics/Statistics, Life Sciences, Computer Science or related field.
• At least 3 years' experience in Biostatistics or Statistical Programming.
• Experience in planning and coordinating programming activities.
• Strong problem-solving and leadership skills.
• Excellent communication skills, both written and verbal.
• Significant knowledge of drug development and clinical research.
• Good knowledge of ICH GCP and worldwide regulatory requirements.
• Ability to multitask and prioritize work.

Responsibilities:

• Ensure that outputs meet quality standards and project requirements.
• Guide and ensure well organized, complete up-to-date project documentation.
• Develop and maintain standard programs, macros, templates, and libraries.
• Contribute to project-specific objectives and team deliverables.
• Responsible for on-time delivery of concurrent programming deliverables.
• Resolve complex statistical programming obstacles and provide guidance.
• Develop annotated CRFs and regulatory submission documentation.
• Develop programming specifications compliant with CDISC standards.
• Develop/validate CDISC compliant datasets and TLFs.
• Serve as a back-up for sponsors and project team for programming activities.
• Review/approve electronic Case Report Forms as required.
• Drive small teams of programmers in programming activities.
• Maintain professionalism, performance, and quality.