Biostatistician
Posted 5 days ago by Radiant Systems Inc
Negotiable
Undetermined
Undetermined
Harlow, England, United Kingdom
Summary: The Biostatistician role involves providing statistical support for observational studies and clinical trials, including authoring and reviewing statistical analysis plans and collaborating with cross-functional teams. The position requires expertise in programming and analysis for Medical Affairs and Real World Evidence (RWE) studies, as well as supporting the development of abstracts, posters, and manuscripts. Candidates should have a strong background in biostatistics or statistics, with significant experience in the pharmaceutical industry and various statistical methodologies.
Key Responsibilities:
- Provide statistical support in protocol development for observational studies and clinical trials.
- Author and review statistical analysis plans, analysis dataset specifications, and shells.
- Collaborate with programming and cross-functional teams in Phase-4 non-interventional studies.
- Develop CRF, validate, and review datasets and results.
- Conduct programming and analysis for Medical Affairs and RWE studies.
- Support the development of abstracts, posters, and manuscripts as deliverables.
Key Skills:
- PhD or MS in Biostatistics or Statistics.
- Experience in the pharmaceutical industry providing statistical input into study design, analysis, and reporting.
- Minimum 4 years of experience with Phase-4 studies, Medical Affairs studies, RWE, or HEOR studies.
- Minimum 4 years of experience with statistical software, SAS, and R.
- Minimum 4 years of experience with SDTM and ADaM data standards.
- Minimum 4 years of experience with Real World Data (RWD) and RWE methodologies.
- Minimum 4 years of experience with advanced statistical models and Machine Learning methods.
Salary (Rate): undetermined
City: Harlow
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Position Summary: Provide statistical support in protocol development for observational studies and/or clinical trials. Author and review of statistical analysis plans, analysis dataset specifications, and shells. Work with programming and other cross-functional teams in Phase-4 non-interventional study to develop CRF, validate and review the datasets and results. Conduct programming and analysis for Medical Affairs, RWE studies. Support develops abstract, poster and manuscript as deliverables. Core Essential Skill sets: Education: PhD or MS in Biostatistics or Statistics Experience in pharmaceutical industry to provide statistical input into the study design, statistical analysis, and reporting of interventional and observational studies Min 4 yrs experience with Phase-4 study, Medical Affairs study, Real World Evience (RWE) or HEOR study. Min 4 yrs experience in statistical software, SAS and R. Min 4 yrs experience with SDTM and ADaM data standards. Min 4 yrs experience with Real World Data (RWD) and RWE methodologies, such as propensity score analysis, causal inference. Min 4 yrs experience with advanced statistical models such as mixed effect model approaches for repeated measures, Machine Learning (ML) methods.