Senior Statistician
Location: [Not specified]
Experience Required: Minimum 5+ years in the Pharmaceutical or CRO industry
Job Type: Full-Time
Job Description:
We are currently seeking a Senior Statistician to join our growing team at Navitas Data Sciences. This role involves high-level statistical consulting, designing and executing statistical analysis for clinical trials (Phases I–V), and leading client-focused study teams. The ideal candidate will possess deep technical expertise in biostatistics and data standards, and will play a pivotal role in regulatory submissions, clinical development, and stakeholder engagement.
Key Responsibilities:
Clinical Statistical Leadership:
Perform statistical analyses for clinical trials across Phases I–V, including ISS (Integrated Safety Summary), ISE (Integrated Efficacy Summary), and publications.
Lead the development and review of study protocols and Statistical Analysis Plans (SAPs).
Design data acquisition trials, assess trends, and analyze results using advanced statistical techniques.
Project Execution:
Develop specifications and implement Tables, Listings, and Figures (TLFs).
Design and apply Analysis Data Set Specifications (ADaM) and ensure alignment with CDISC and SDTM standards.
Write the statistical sections of Clinical Study Reports, ISS, and ISE documents.
Strategic & Regulatory Support:
Present data in meaningful formats and forecasts using appropriate statistical models.
Represent clients in regulatory agency meetings (e.g., FDA).
Develop and publish white papers and speak at industry conferences.
Team & Client Management:
Lead one or more studies for clients and mentor cross-functional project teams.
Interface with client senior management and stakeholders.
Manage technical project activities, directing statisticians and statistical programmers.
Desirable Skills and Experience:
5+ years of experience in the Pharmaceutical or CRO industry in a statistical capacity.
Proficient in CDISC, SDTM, ADaM, and advanced statistical software (e.g., SAS).
At least 2 years of experience in technical project management of statistical teams.
Strong presentation and publication history in scientific and industry platforms.
Excellent interpersonal, management, and communication skills.
Recognized authority in statistics by industry peers and clients.
Ability to convey complex statistical findings to executive-level stakeholders.
Estimated Salary: ₹22 LPA – ₹35 LPA (based on experience and expertise)
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