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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