Principal Biostatistician

2 weeks ago

Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per year
Job DescriptionKey Responsibilities
  • Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician.
  • Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.
  • Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.
  • Project level-May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables.
  • Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings.
  • Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level
  • Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings.
  • External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.
Role Requirements :
  • MS (in Statistics or equivalent) with 7 years relevant work experience or PhD (in Statistics or equivalent) with 3 years relevant work experience
  • Fluent English (oral and written) Good communication and presentation skills
  • Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role.
  • Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills.
  • Proficiency in use of statistical software packages (e.g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives.
  • Good understanding of Franchise/Therapeutic Area and or regulatory activities.
  • Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics
Commitment to Diversity and Inclusion:

Novartis

  • Principal Biostatistician

    23 hours ago

    Hyderabad, Telangana, India Statistics & Data Corporation (SDC) Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Principal BiostatisticianStatistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical...

  • Principal Statistical Programmer

    2 weeks ago

    Hyderabad, Telangana, India IQVIA Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Principal Statistical Programmer Bachelor's degree from reputable university preferably in science/ mathematics related fields · Preferred SAS certification Technical Skills Requirements · Must have expertise of SAS Base, and good knowledge of SAS graph and SAS Macros. · Capable of implementing more advanced statistical ...

  • Principal Biostatistician

    1 week ago

    Hyderabad, Telangana, India Syneos Health Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Good to Have SkillsProficiency in CDISC standards, particularly ADaM (Analysis Data Model) and SDTM (Study Data Tabulation Model).Experience in creating and validating ADaM datasets, ensuring they are analysis-ready and compliant with regulatory requirements.Hands-on experience with efficacy analysis, including the creation of statistical analysis plans...

  • Principal Biostatistician

    7 days ago

    Hyderabad, Telangana, India Syneos Health Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Role & responsibilitiesCollaborates with field experts in Research and Pre-Clinical Development to plan, execute and analyze relevant experiments independently, notablydesign of experiments feasible under given lab conditions,support of sample-size calculations and application for animal testing licenses,randomization,data transfer into appropriate stats...

  • Principal Statistical Programmer

    2 weeks ago

    Hyderabad, Telangana, India IQVIA Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Bachelor's degree from reputable university preferably inscience/ mathematics related fieldsPreferred SAS certificationTechnical SkillsRequirementsMust have expertise of SAS Base, and good knowledge ofSAS graph and SAS Macros.Capable of implementing more advanced statisticalprocedures as per specifications provided by biostatistician.Must have excellent...

  • Senior Principal Business Analyst

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time ₹ 80,00,000 - ₹ 2,00,00,000 per year

    SummaryWe are looking for a Senior Business Analyst to join our Technology & Scientific Computing(TSC) team in Development. Within Development, our core statistical computing environment is used for submissions as well as exploratory data science related activities. Hosting a wide range of scientific software, the goal is to provide a robust and...

  • Principal Biostatistician

    7 days ago

    Hyderabad, India Statistics & Data Corporation (SDC) Full time

    Principal Biostatistician Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical...

  • Principal Biostatistician

    7 days ago

    Hyderabad, India Statistics & Data Corporation (SDC) Full time

    Principal Biostatistician Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical...

  • Apply Now! Principal Biostatistician

    2 weeks ago

    Hyderabad, Telangana, India Statistics & Data Corporation (SDC) Full time

    Principal Biostatistician Statistics Data Corporation SDC a specialized contract research organization CRO headquartered in Arizona delivering top-tier clinical trial services to pharmaceutical biologic and medical device diagnostic companies since 2005 SDC providing a technology enabled service offering to provide clients with both clinical...

  • [24/09/2025] Principal Biostatistician

    2 weeks ago

    Hyderabad, India Statistics & Data Corporation (SDC) Full time

    Principal Biostatistician Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical...

  • Principal Biostatistician

    3 weeks ago

    Hyderabad, India Syneos Health Full time

    Role & responsibilities Collaborates with field experts in Research and Pre-Clinical Development to plan, execute and analyze relevant experiments independently, notably design of experiments feasible under given lab conditions, support of sample-size calculations and application for animal testing licenses, randomization, data transfer into appropriate...

  • Principal Biostatistician

    3 days ago

    Hyderabad, Telangana, India Novartis Full time

    **Summary**: Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design...

  • Principal Statistical Programmer

    3 weeks ago

    Hyderabad, India IQVIA Full time

    Bachelor's degree from reputable university preferably in science/ mathematics related fields Preferred SAS certification Technical Skills Requirements Must have expertise of SAS Base, and good knowledge of SAS graph and SAS Macros. Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician. Must have...

  • Assoc Principal Statistical Programmer/Sr Stat Programmer

    1 week ago

    Hyderabad, India IQVIA Full time

    • Must have expertise of SAS® Base, and good knowledge of SAS® graph and SAS® Macros.• Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.• Must have excellent knowledge of CDISC standards (SDTM and ADaM and TFL)• Thorough understanding of relational database components and theory.•...

  • Principal Statistical Programmer

    2 weeks ago

    Bengaluru, Chennai, Hyderabad, India ACL Digital Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    ROLES and RESPONSIBILITIES:Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiencySupport the development and implementation of a programming ecosystem to enable successful project deliverablesReview statistical analysis plans, mock-shells, database set-up...

  • Principal Statistical Programmer

    5 days ago

    Hyderabad, India Syneos Health Clinical Full time

    **Description** **Statistical Programmer II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health...