Senior Statistician - RWE/Observational Research - Pharma

Remote Opportunity

Job Title: Senior Statistician RWE or Observational research

We are actively recruiting a Senior Level RWE/observational research Statistician This is a remote role based anywhere in India

Role and responsibilities:

- Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies (including Phase IV) or programs. Experience with SAS, R, Python and healthcare claims data.

- Protocols: Provide study design, calculate sample size, develop randomization specifications and write statistical analysis plans to address study objectives. Ensure alignment of the protocol with project and functional standards. Conduct a quality review of protocol and provide appropriate feedback.

- Database Activities: Assist in identifying scientifically appropriate data collection instruments. Ensure data collection is free of bias. Provide programming specifications for derived variables and analysis datasets. Assist with the development and implementation of project-specific data standards. Identify and report data issues or violations of study assumptions. Guide programmers and data managers in preparing for database lock. Ensure the accuracy of data released for statistical analysis.

- Statistical Analyses: Explain statistical concepts to non-statisticians. Develop analysis plans ensuring statistical methods are appropriate with the study design with detail for programming. Ensures internal consistency of analysis plans. Perform statistical analyses per the SAP. Independently anticipate need and implement complex statistical methodology. Evaluate available statistical methodology and software and the need for novel statistical methodology.

- Reports and Publications: With project team, develop strategy for data presentation and inference. With supervision, write statistical methods and other sections of protocols, publications, etc., ensuring document templates followed. Identify and implement corrections to flaws in statistical interpretation. Collaborate in publication of scientific research. Ensure analyses conducted as planned with accuracy and internal consistency of writing including tables, listings and figures.

Requirements for consideration:

- PhD or MSc in Statistics or Biostatistics (with at least 10 years of relevant experience)

- Deep experience with RWE data

- Experienced in the pharmaceutical industry to provide statistical input into the design, analysis, and reporting of clinical trials and observational studies.

- Familiar with SDTM and ADaM data standards.

- Familiar with mixed effect model approaches for repeated measures is preferred.

- Familiar with machine learning methodologies, such as LASSO, clustering, and random forest is a plus.

- Familiar with real-world evidence methodologies, such as causal inference, is a plus

- Excellent oral and written communication skills

- Experienced in SAS and R