Principal Biostatistician

About The RoleServes as the overall statistical lead on one or more clinical programs and will provide statistical input in design, analysis, and reporting of clinical studies to expedite conduct and evaluation of clinical trials and basic research. Leads statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical investigators to determine protocol design. Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility.Your Contributions (Include, But Are Not Limited To):Provides statistical leadership and strategic input to the Dev Core Team in all areas of drug development and commercialization, including the overall clinical development plan, publication planning, and studiesRepresents Biometrics on one or more Dev Core Team or clinical subteam (as appropriate for the clinical program).Collaborates with Clinical Development, Medical Writing, and Regulatory Affairs project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports.Identifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines appropriate statistical methods of analysis for clinical studies.Reviews and approves clinical study database data validation specifications, data review plans, coding guidelines, and data transfer agreements.Prepares, reviews, and approves statistical analysis plans.Works closely with statistical programmers to ensure that statistical methods are implemented correctly in statistical programs and collaborates with programmers in developing formats and specifications for summary tables, figures, and listings.Oversees and monitors CRO performance of statistical analyses and programming to ensure that timelines are met, resource issues are identified and resolved, and all applicable data and programming standards are adhered to.Provides biostatistical support to nonclinical, medical affairs, and commercial areas of the company as needed, including consulting and statistical analysis.Assists in the development of department standard operating procedures and statistical analysis plan and report templates, data standards, and selection and implementation of statistical software.Mentors junior members of the biostatistics team and supervises their work on an as-needed basis.Researches, identifies, develops, and implements new and innovative statistical methods for the analysis of clinical study data and adaptive study designs.Assumes a leadership role in clinical program(s), with the responsibility of ensuring that the statistical requirements are met for all projects in the program(s).Performs other duties as assigned.Requirements:Master's degree in statistics or biostatistics, or a related discipline AND 4+ years of experience in the design, analysis, and reporting of clinical studies. Demonstrated experience in SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data. Significant experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets. Proven interaction directly with regulatory authorities highly desirable. ORPhD in statistics or biostatistics, or a related discipline preferred AND 2+ years of related experienceDemonstrated ability to provide statistical leadership and strategic input regarding the overall drug development plan and commercialization activitiesStrong organizational skills and proven ability to effectively lead a project to successful completionSignificant expertise in the design, analysis, and reporting of clinical studiesAdvanced knowledge of the SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study dataAdvanced knowledge of working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasetsThorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study dataExpertise in interacting directly with regulatory authorities highly desirableMaintains expertise in state-of-the-art data manipulation and statistical analysesHas knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplinesWorks to improve tools and processes within functional areaDeveloping reputation inside the company as it relates to area of expertiseAbility to work as part of and lead multiple teamsExhibits leadership skill and ability, typically leads lower levels and/or indirect teamsExcellent computer skillsExcellent communications, problem-solving, analytical thinking skillsSees broader picture, impact on multiple departments/divisionsAbility to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiencyExcellent project management skillsNeurocrine Biosciences is an EEO/Disability/Vets employer.We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.