Sr. Analyst, Stats Programming

Neurocrine Biosciences

San Diego, CA

JOB DETAILS
SKILLS
Analysis Skills, Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Trial, Code of Federal Regulations, Communication Skills, Computer Programming, Computer Science, Contract Research Organization (CRO), Data Management, Data Sets, Data Structures, Documentation, Documentation Standards, FDA (Food and Drug Administration), Health Plan, ICH Regulations, Incentive Programs, Industry Standards, Interpersonal Skills, Mathematics, Mentoring, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Organizational Skills, People Management, Prescription Drugs, Problem Solving Skills, Programming Libraries, Programming Methodologies, Project/Program Management, R Programming Language, Regulations, Relational Databases (RDBMS), Requirements Management, Standards Development, Statistical Analysis System (SAS), Statistical Programming Languages, Statistics, Team Player, Test Plan/Schedule, Time Management, XML (EXtensible Markup Language)
LOCATION
San Diego, CA
POSTED
1 day ago

About the Role Designs, develops, tests, maintains, validates, and documents SAS programs to evaluate clinical data and meet the project requirements for SAS statistical programming efforts for clinical and non‑clinical projects and studies. Provides technical expertise to the development of programming standards and procedures.Key Responsibilities Serves as the primary project team representative, delegating work as appropriateGenerates SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domainsGenerates analysis data sets, tables, figures, and listings to support the analysis of clinical trials dataReviews output across programs to ensure consistencyReviews, maintains, and approves study documents per standard proceduresProvides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad‑hoc requestsPrograms, tests, and documents global utility programs and tools in accordance with standards and validation proceduresProvides technical expertise to the development of programming standards and procedures, technical expertise in the areas of analysis and reportingParticipates in the development and/or maintenance of departmental procedures and standardsPerforms programming using techniques such as macro language, advanced data manipulation, and statistical proceduresImplements data management plans designed to meet project and protocol deadlinesActs as a liaison between clinical management, subcommittees and project teams as neededMay train and mentor new programmersPerforms other duties as assignedKey Skills and Qualifications BS/BA degree in computer science, mathematics, statistics, or related discipline AND 4+ years experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph). In addition, must have at least three years of experience serving in a supervisory or lead capacity.Experience managing projects OR Master's degree in computer science, mathematics, statistics, or related discipline AND 2+ years of similar experience noted above OR PhD in computer science, mathematics, statistics, or related discipline AND similar experience as noted aboveUnderstands 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 skillsStrong interpersonal skills to effectively work in a team environmentExcellent organizational skills, time management, and ability to coordinate workload and meet established deadlinesProficiency with Word, Excel, and PowerPoint is required as is the ability to communicate effectively both verbally and in writingDemonstrates strong knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelinesStrong programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similarStrong knowledge of SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domainsStrong knowledge of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systemsStrong understanding of relational databases and experience working with complex data systemsBenefits 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.Neurocrine Biosciences is an EEO/Disability/Vets employer.#J-18808-Ljbffr

About the Company

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Neurocrine Biosciences