Senior Data Analyst
18 hours ago
Lead Statistical ProgrammerWe are seeking a highly experienced Lead Statistical Programmer to drive innovation in patient treatment by working closely with pharmaceutical clients.Key Responsibilities:Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studiesDevelop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphsDeliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needsParticipate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelinesSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesUnderstand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macrosParticipate in the development of CRFs, edit check specifications, and data validation plansProvide review and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goalsProvide review and/or author SOPs and/or Work Instructions related to statistical programming practices.Requirements and Qualifications:A Master's degree in Statistics or related field is requiredAt least 5 years of experience as a senior statistical programmer in a pharmaceutical company or CROStrong knowledge of regulatory requirements, GCP, and electronic submissionsExcellent leadership and communication skillsExperience with data management systems, database design, and relational databasesAbility to work in a fast-paced environment and manage multiple projects simultaneouslyFamiliarity with CRF design and development, data validation plans, and edit checksProficiency in writing SQL queries, shell scripting, and SAS/PGM codingPossess strong problem-solving skills and attention to detailWhat We Offer:A dynamic and collaborative work environment that encourages growth and professional developmentA competitive salary package with bonus structureA comprehensive benefits program including medical, dental, and vision insuranceA generous paid time off policy and flexible working hoursA retirement plan with employer matchingAbout Us:We are a leading provider of clinical research services dedicated to delivering high-quality solutions that support our clients' success.
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