Biostatistician
Posted Today by 1762949530
Negotiable
Outside
Remote
USA
Summary: Stefanini Group is seeking a Biostatistician to serve as a subject matter expert in risk management, providing statistical support for observational studies and clinical trials. The role involves authoring and reviewing statistical analysis plans, collaborating with cross-functional teams, and conducting programming and analysis for Medical Affairs and Real World Evidence studies. Candidates should possess a strong background in biostatistics, statistical software, and relevant experience in the pharmaceutical industry.
Key Responsibilities:
- Provide statistical support in protocol development for observational studies and clinical trials.
- Author and review statistical analysis plans, analysis dataset specifications, and TFL shells.
- Collaborate with programming and cross-functional teams in Phase-4 non-interventional studies.
- Conduct programming and analysis for Medical Affairs and Real World Evidence 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 and analysis.
- Minimum 4 years of experience with Phase-4 studies, Medical Affairs studies, or Real World Evidence methodologies.
- Minimum 4 years of experience with statistical software, specifically SAS and R.
- Minimum 4 years of experience with SDTM and ADaM data standards.
- Minimum 4 years of experience with Real World Data and RWE methodologies.
- Minimum 4 years of experience with advanced statistical models and Machine Learning methods.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: IT
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The resource shall act as subject matter expert to assist functional owners of elements of the risk management file with planning and updates.
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 TFL 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 develop abstract, poster and manuscript as deliverables.
Core Essential Skill sets:1. Education: PhD or MS in Biostatistics or Statistics2. Experience in pharmaceutical industry to provide statistical input into the study design, statistical analysis, and reporting of interventional and observational studies.3. Min 4 yrs experience with Phase-4 study, Medical Affairs study, Real World Evidence (RWE) or HEOR study.4. Min 4 yrs experience in statistical software, SAS and R.5. Min 4 yrs experience with SDTM and ADaM data standards.6. Min 4 yrs experience with Real World Data (RWD) and RWE methodologies, such as propensity score analysis, causal inferenceMin 4 yrs experience with advanced statistical models such as mixed effect model approaches for repeated measures, Machine Learning (ML) methods.
Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like Americas, Europe, Africa and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting, company with global presence. We are CMM Level 5 company.
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