Job purpose
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 deliverables
- In-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.
- Excellent oral & written communication skills.
- Change mindset approach to wider working.
Job purpose
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 deliverables
- In-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.
- Excellent oral & written communication skills.
- Change mindset approach to wider working.
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