Senior Associate, Statistical Programming

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Requirements:

• Bachelor’s Degree in Mathematics/Statistics, Life Sciences, Computer Science, or related field.
• Fluent English (oral and written).
• At least 2 years’ experience in Biostatistics or Statistical Programming within the pharmaceutical industry.
• Experience in planning and coordinating programming activities and leading programming teams is strongly preferred.
• Ability to multitask and prioritize work, paying close attention to detail, timeliness and quality.
• Strong problem-solving and leadership skills.
• Excellent team working characteristics for cross-functional teams.
• Significant knowledge of drug development and clinical research.
• Good knowledge of ICH GCP and worldwide applicable regulatory requirements.
• Ability to operate in a fast-paced environment.
• Excellent time management and planning skills.
• Excellent communication skills, both written and verbal.

Responsibilities:

• Create outputs that meet quality standards and project requirements.
• Maintain well organized, complete up-to-date project documentation, and verification/quality control documents.
• Read and understand the Study documents and provide feedback.
• Contribute to project-specific objectives and team deliverables.
• Responsible for on-time delivery across concurrent programming deliverables.
• Develop annotated CRFs and regulatory submission documentation.
• Develop programming specifications and support clinical study reports.
• Develop/validate CDISC compliant datasets and TLFs.
• Maintain a high level of professionalism and quality.
• Undergo Regulatory trainings and other statistical programming duties.