Senior Statistician
2 days ago
Oxford
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, • 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.