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Statistical Programmer Lead

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Statistical Programming LeadWe are seeking an experienced Statistical Programming Lead to join our team. As a key member of this program, you will work independently with minimal supervision, providing expert technical support to team members and overseeing CRO programmers to ensure data summaries are delivered in a consistent, high-quality manner.ResponsibilitiesDevelop SDTM, ADaM specifications, datasets, reviewer's guide, and define.xml files for multiple studiesGenerate SAS programs which produce 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 affecting 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) to ensure meeting project timelines and goalsProvide review and/or author SOPs and/or Work Instructions related to statistical programming practicesRequirementsAs a successful candidate, you will possess:Expert knowledge of statistical programming concepts, techniques, and methodologiesStrong understanding of data management principles and best practicesExcellent problem-solving skills with attention to detail and quality assuranceEffective communication and collaboration skills to work with cross-functional teamsAbility to manage competing priorities, deadlines, and deliverables in a fast-paced environmentProficiency in SAS programming language and experience with other programming languages such as RExperience working with clinical trials data and regulatory submissionsBenefitsWe offer a comprehensive benefits package, including:Competitive salary and bonus structureOpportunities for career growth and professional developmentCollaborative and dynamic work environmentRecognition and rewards for outstanding performanceWhat We OfferWe are committed to creating a diverse and inclusive work environment that fosters innovation, creativity, and growth. Join our team and be part of a global organization that makes a difference in people's lives.