We are seeking a highly skilled Biostatistician to join our team in Hyderabad. In this role, you will provide expert support and functional and technical knowledge to ensure the scientific integrity and validity of clinical development, early development, and/or research projects. You will play a crucial part in the full lifecycle of producing key data and reports, from evaluating requirements to coordinating validation and providing quantitative analytical support. This position also involves providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. You may also contribute statistical expertise to research or other R&D areas. Additionally, you'll be responsible for advising and leading the planning, development, and implementation of industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. You will provide expert support and stellar customer focus to business users and teams on their use of various data-related tools and processes. About the Role: Key Responsibilities Study Level Responsible for all statistical tasks on assigned trials, performing mid- to high-complexity trials independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, and reporting activities. Contribute to planning and execution of exploratory analyses, PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive, and implement novel methods and innovative trial designs 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, external consultants, and other external parties with appropriate oversight. Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions, explaining statistical concepts clearly to non-statisticians and providing 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. Ensure 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, representing Biostatistics and Pharmacometrics as part of the development plan with oversight. Collaborate with clinical, regulatory, and other strategic functions to drive quantitative decision-making in assigned indications/programs 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 contribute to project team preparation for Health Authority (HA) Advisory Committees and meetings. Franchise or Global Line Function Level Significantly contribute to initiatives at the 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 acceptance of innovative methods within and outside the organization, 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, external consultants, and other external parties with appropriate oversight. Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings. Role Requirements MS (in Statistics or equivalent) with 7+ years of relevant work experience OR PhD (in Statistics or equivalent) with 3+ years of relevant work experience . Fluent English (oral and written) with good communication and presentation skills. Ability to influence decisions that directly impact the trial/project and team's 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 modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in the 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. Adherence to good business ethics.