Senior Statistician

Reporting to the Director of Biometrics, the Senior Statistician will be responsible for the provision of statistical expertise across clinical programs. This includes creation/review of statistical analysis plans, SAS and R programming of descriptive and inferential analysis, and statistical support for the writing of clinical protocols and clinical study reports for Blue Earth Diagnostics sponsored/managed clinical trials. The Senior Statistician will also contribute scientific input concerning statistical approaches to be used in the design of clinical studies.

Main Responsibilities, Activities, Duties and Tasks

• Act as study statistician on assigned clinical studies as part of the project team.
• Support the oversight of biometrics vendors supporting Blue Earth Diagnostics sponsored/managed studies, including input into timelines, deliverables, and quality of vendor outputs.
• Provide statistical input and support into trial design and protocol development.
• Author/review statistical analysis plans.
• Review database setup documents in clinical study setup (e.g., Data Management Plan, Case Report Forms, Database Specifications, Edit Check Specifications).
• Support the data review in clinical studies (i.e., Tables/Figures/Listings, Clinical Data Interchange Standards Consortium (CDISC) data {Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM)} and data submission packages {e.g., define.xml, Pinnacle21, Data Reviewer Guides}).
• Contribute to New Drug Application (NDA) / Market Authorisation Application (MAA) documentation, including review of clinical study reports.
• Coordinate closely with other functions including Medical, Clinical Operations, Imaging, and Regulatory Affairs.
• Other duties as determined by business needs.

Education

BSc (Hons) in mathematical or scientific discipline; post graduate degree (MSc/PhD) in statistical science.

Professional Experience, Knowledge & Technical Skills

• Demonstrated experience in:
• Application of statistical methods in clinical trials
• Contributing to planning of data analysis activities in clinical trials, including data handling in electronic data capture platforms
• Working with contract vendors supporting data management, programming, and statistical activities
• Supporting regulatory submission activities, including data submission standards and contribution to NDA/MAA deliverablesIn-depth understanding of CDISC Standards
• In-depth understanding of the drug development process, including exposure to regulatory filings
• Good understanding of SAS programming concepts, good programming practices and techniques related to drug development
• Knowledge of Good Clinical Practice (GCP) regulations/requirements
• Oncology and diagnostic imaging experience desirable

Soft Skills – Company Values & Behaviours

• Ability to work in a high paced team environment, meet deadlines, & prioritize work on multiple projects
• Ability to accurately estimate effort required for project related programming activities.
• Experience working within cross-functional and matrixed organizations.
• Change mindset approach to wider working.

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