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Job Title / Primary Skill: Sr Biostatistician
Years of Experience: 8 to 10 Years
Job Location: PAN India
Qualification: Master's in Statistics
Roles and Responsibilities:
- Develop statistical methods sections of protocols and review case report forms (CRFs).
- Prepare analysis plans and write specifications for analysis files, tables, and figures.
- Communicate with clients regarding study protocol or statistical analysis issues as they arise.
- Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.
- Interpret analyses and write statistical sections of study reports.
- Accountable for controlling costs and maximizing revenue recognition.
- Provide training, guidance and mentorship to lower level and new staff.
Essential Functions
- Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken.
- Leadership: Perform statistical team lead role on single studies. Works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget.
- Data Management: Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions.
- Statistical Analysis Plan (SAP) and Shells: Authors or performs quality control review (QC) of SAPs and shells.
- Datasets: Writes and maintains programming specifications.
- Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs.
- Timelines: Plans and documents timelines, forecasts resource needs.
- Financials: Shares accountability (with resource managers) for the financial success of assigned studies.
- Knowledge Sharing: Helps train staff regarding operational items. Mentors junior staff.
- Risk Management: Identifies risks to project delivery and/or quality and proposes solutions to mitigate risks.
- Study Start up: Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.
- Protocol: Authors or performs quality control (QC) review of the statistical section of a protocol.
- Proposals: May be able to review and comment on proposals/budgets at a study level.
- Clinical Study Report (CSR): Reviews or drafts CSR or statistical report.
- Customer: On occasion, may serve as primary point of contact for customer.
- Lock and Unblinding Process: Handles the database lock and unblinding process.
- Other Responsibilities: As defined on ad-hoc basis by managers.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research
Industries
Research Services