Senior Principal Biostatistician

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 specifications interface to programmers report programming coordinate validation and rollout activities along with providing quantitative analytical support Provide statistical support for regulatory submissions including planning analysis and reporting of clinical safety and efficacy summaries May also provide statistical support to research or other R D areas -Responsible for advising leading the planning development implementation of Industry CDISC and regulatory compliant high quality clinical data standards infrastructure or automation technologies Providing expert support and stellar customer focus to business users and teams on their use including -Data standard collection tools in EDC CRFs edits checks derivations core configurations -Data transfer specifications -Analysis data TFL standards Define -Automation solutions technologies -Business infrastructure business rules and guidelines About the Role The Senior Principal Biostatistician is responsible and accountable for all statistical work scientific and operational for one or more assigned trials in collaboration with the clinical trial team Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision Proposes and leads implementation of modern and innovative trial experimental designs statistical models analysis and data exploration methodologies at the study or project level Key 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 Minimum requirements MS in Statistics or equivalent with 7 years relevant work experience or PhD in Statistics or equivalent with 5 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 is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to diversityandincl india novartis com and let us know the nature of your request and your contact information Please include the job requisition number in your message Skills Desired Automation Biostatistics Clinical Trials Computer Programming Metadata Management Statistical Analysis