Sr. Biostatistician

About the RoleServes as the statistical lead for multiple clinical studies, representing Biometrics on one or more study management teams. Provides statistical direction and support for study design, analysis, and reporting, in order to expedite the conduct and evaluation of clinical trials and basic research. Performs statistical analysis of clinical trial data._Your Contributions (include, but are not limited to):Represents Biometrics on one or more study management teams, as appropriate for the clinical programCollaborates with Clinical Development and Medical Writing project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reportsIn collaboration with the program lead statistician, identifies appropriate, efficient experimental designs and defines analysis endpoints. Develops randomization plans and determines appropriate statistical methods of analysis for clinical studiesReviews clinical study database data validation specifications, data review plans, coding guidelines, and data transfer agreementsPrepares statistical analysis plans for approvalWorks 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 listingsMonitors and reports on 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 toProvides biostatistical support to nonclinical, medical affairs, and commercial areas of the companyAssists in the development of department standard operating procedures and statistical analysis plan and report templates, data standards, and selection and implementation of statistical softwarePerforms independent research as needed and explores, develops, and implements new statistical methods for the analysis of clinical study dataPerforms other duties as assignedRequirements:Master's degree in statistics or biostatistics, or a related discipline AND 4+ years of relevant experience ORPhD in statistics or biostatistics, or a related discipline preferred AND 2+ years of relevant experienceUnderstands key business drivers and uses this understanding to accomplish workHas strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areasProficient with tools and processes that support work conducted by functional areaAbility to work as part of a team; may train lower levelsExcellent computer skillsStrong communications, problem-solving, analytical thinking skillsDetail oriented yet can see broader picture for departmentAbility to meet multiple deadlines, with a high degree of accuracy and efficiencyStrong project management skillsSolid expertise in the design, analysis, and reporting of clinical studiesStrong organizational skills and proven ability to effectively lead the statistical aspects of multiple clinical studies simultaneouslyStrong knowledge of the SAS programming language with a specific emphasis in SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study dataGood knowledge of CDISC and related FDA standards for specification and creation of SDTM and ADaM datasetsBroad knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study dataExperience in interacting directly with regulatory authorities highly desirableMaintains expertise in modern data manipulation and statistical analysis methodologiesNeurocrine 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 $110,800.00-$151,000.00. 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 20% 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.