Principal Biostatistician

6 months ago

Bengaluru, India Veranex, Inc. Full time

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.
- Minimum Requirement:

- Master’s degree or international equivalent and 8+ years of relevant work experience; PhD or international equivalent and 5+ years of relevant work experience
- Master’s degree or PhD or international equivalent in statistics, applied statistics or biostatistics
- In-depth knowledge of ICH GCP guidelines
- Advanced knowledge of creation and review of safety and efficacy data analysis
- Advanced knowledge of relevant Data Standards
- Advanced knowledge of the SAS computing package
- Thorough understanding of statistical analysis plan (SAP) and mock shell creation and review
- Thorough understanding of statistical issues in clinical trials
- Excellent written and oral communication skills including conflict management and the ability to negotiate
- Excellent attention to detail
- Advanced analytical skills and ability to prioritize
- Advanced ability to plan, supervise, implement, and monitor the statistical processes for clinical studies
- Ability to solve complex problems
- Advanced ability to effectively manage multiple tasks and projects
- Ability to lead and coordinate small teams
- Roles and Responsibilities:

- Leads the production, review, and quality control of statistical deliverables.
- Performs sample-size calculations, generates randomization lists and writes statistical methodology sections for study protocols.
- Provides broad statistical support, including protocol development and trial design.
- Reviews statistical analysis plans, derived datasets, tables, listings, and figures.
- Reviews protocol to ensure statistical integrity and optimal study design.
- Coordinates and leads project team. Interacts with clients as key statistical contact.
- Trains and mentors new or junior statisticians on statistical methods.
- Participates in business development activities by providing input to Request for Proposals.
- Provides input into and reviews CSR and other summary reports.
- Prepares or reviews Statistical Analysis Report (SAR).
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results. Networks with key contacts outside area of expertise.
- Having wide-ranging experience, uses professional concepts to resolve complex issues in creative and effective ways
- Determines methods and procedures for new assignments and may coordinate activities of other team members.

  • Principal Biostatistician

    1 month ago

    Bengaluru, Karnataka, India Icon plc Full time

    Principal Biostatistician, Office or Home, India ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Principal...

  • Senior / Principal Biostatistician

    6 months ago

    Bengaluru, India ClinChoice Full time

    Senior / Principal Biostatistician Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so...

  • Biostatistician Consultant

    2 weeks ago

    Bengaluru, Karnataka, India Lilly Full time

    We're seeking a Senior Principal Biostatistician with a strong scientific mindset to join our team.About the RoleThis role is focused on developing and implementing statistical methods for clinical trials, collaborating with cross-functional teams, and providing expert analysis to support regulatory submissions.Key Responsibilities:Design and develop...

  • Biostatistician

    6 months ago

    Bengaluru, Karnataka, India ClinChoice Full time

    ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Principal Biostatistician on a permanent basis. You will work on projects from our varied client base, ranging...

  • Principal Biostatistician

    6 months ago

    Bengaluru, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Principal Biostatistician

    4 months ago

    Bengaluru, Karnataka, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Principal Biostatistician

    6 months ago

    Bengaluru, Karnataka, India Parexel Full time

    **Operational Execution** Provide broad statistical support, including trial design, protocol and CRF development on specific studies Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents Perform sample-size calculations,...

  • Senior Principal Biostatistician

    6 months ago

    Bengaluru, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Purpose: The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Clinical Project Statistician is...

  • Premier research | principal statistical programmer

    3 days ago

    Bengaluru, India Premier Research Full time

    What you'll be doing:Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shellsPerforms quality control (source code review, double-programming and log review) of SAS programsDevelops SAS programs to generate CDISC and other analysis data sets as outlined by respective specificationsPrepares specifications for CDISC and...

  • Premier Research | Principal Statistical Programmer | bangalore

    2 weeks ago

    Bengaluru, India Premier Research Full time

    What you'll be doing:Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shellsPerforms quality control (source code review, double-programming and log review) of SAS programsDevelops SAS programs to generate CDISC and other analysis data sets as outlined by respective specificationsPrepares specifications for CDISC and...

  • Principal Statistical Programmer

    3 weeks ago

    Greater Bengaluru Area, India Premier Research Full time

    What you'll be doing:Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shellsPerforms quality control (source code review, double-programming and log review) of SAS programsDevelops SAS programs to generate CDISC and other analysis data sets as outlined by respective specificationsPrepares specifications for CDISC and...

  • Principal Statistical Programmer

    3 weeks ago

    Greater Bengaluru Area, India Premier Research Full time

    What you'll be doing: Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells Performs quality control (source code review, double-programming and log review) of SAS programs Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications Prepares specifications for CDISC...

  • Statistical Leadership Role for Complex Studies

    3 weeks ago

    Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

    FORTREA, a leading global contract research organization, is seeking a highly skilled Principal Biostatistician to join our FSP team in India.About the RoleThis exciting opportunity involves leading complex studies such as NDA submissions or multi-protocol programs, coordinating activities across multiple locations, and providing statistical oversight. You...