Shashidhar Joshi

Senior Director - Biostatistics (Global) | Strategic Biostatistics Leader | Expertise in Clinical Development Programs | Statistics | SAS/R Programing | Business Development and pre-sales activities in Biostatistics

Role
Senior Director - Biostatistics (Global) at Sitero
Location
Bengaluru, KA, IN
LinkedIn followers
500 followers

About Shashidhar Joshi

Over 20 years of experience in quantitative drug development, statistical analysis, and…

Experience

  1. Senior Director - Biostatistics (Global)

    Sitero

    May 2025 — Present · Bengaluru South, IN

    Lead global biostatistics and statistical programming teams across multiple geographies and therapeutic areas, ensuring scientific excellence and regulatory compliance.Provide strategic oversight for clinical trial designs, estimands framework, and statistical methodologies across early and late-phase studies.Serve as a senior scientific advisor to sponsors, contributing to protocol development, SAP reviews, and regulatory submission strategy.Drive business development through pre-sales support, proposal review, bid defense participation, and strategic partnership discussions.Collaborate with senior leadership to define departmental vision, talent strategy, and long-term growth initiatives.Champion innovation in adaptive trial designs, Bayesian methods, and integration of real-world data for complex analyses.Lead implementation of automated workflows and quality assurance processes to enhance programming and analysis efficiency.Ensure timely and accurate delivery of CDISC-compliant datasets (SDTM, ADaM) and submission packages (define.xml, reviewer guides).Oversee process improvement, KPI tracking, and governance models for sponsor accounts and functional delivery.Represent the company in external forums, including regulatory interactions, professional associations, and industry working groups.

Education

  • Mangalore University

    M.Sc.

  • Indian Institute of Management Bangalore

    Executive General Management Program (EGMP)

    2015 — 2015

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Shashidhar Joshi — Senior Director - Biostatistics (Global) at Sitero in Bengaluru, KA, IN | Unifers