Quanticate

General

• Designing and analysing clinical studies, including input into protocols, Statistical Analysis Plans and sample size calculations
• Programming and quality controlling derived datasets and CDISC compliant datasets
• Producing and reviewing Tables, Listings and Figures
• Providing peer review of statistical and programming deliverables
• Ensuring all outputs meet internal SOPs, client requirements and regulatory expectations
• Manage assigned project work independently, communicate clearly with sponsors when required, and flag risks that could affect timelines or data quality
• Line manage assigned team members, providing mentorship, training and performance feedback

Senior Statistician I/II

Risk

• Lead the preparation, authoring, review, and updating of Risk Management Plans (RMPs) for regulatory submissions and post-approval activities.
• Develop RMPs in support of Marketing Authorisation Applications (MAAs) and variations.
• Ensure RMPs comply with regional pharmacovigilance and regulatory requirements.
• Collaborate with cross-functional teams including Regulatory Affairs, Clinical Development, Medical Affairs, Safety, and Quality.
• Provide strategic pharmacovigilance input regarding safety concerns, risk minimisation measures, and pharmacovigilance activities.
• Support responses to health authority questions related to risk management and pharmacovigilance documentation.
• Contribute to the continuous improvement of pharmacovigilance processes and documentation standards.

Pharmacovigilance Consultant – Risk Management Plans

Software Engineer

• - Program tables, figures and listings and derived datasets according to the request description.
• - Perform quality control checks and complete quality control documentation for programming plans, specifications, outputs/derived datasets.
• - Perform other reasonable programming tasks as requested by management.
• - Follow appropriate Project Management procedures.
• - Communicate effectively with OR team.
• - Provide input to improvements to processes, procedures and standards.
• - Support the training and development of other programmers.

Senior Statistician I/II

Pharmacovigilance Consultant – Risk Management Plans

Senior Programmer I/II – Real World Data, Evidence