Principal Statistical Programmer

The Principal Statistical Programmer works independently with only concept level instruction and very little supervision; tracks progress and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.\n\nResponsibilities\nAs a Principal Statistical Programmer, your responsibilities will include:\nGenerate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies\nDevelop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs\nDeliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs\nParticipate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines\nSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses\nUnderstand and follow FDA regulations which affect the reporting of clinical trial data.

This includes good clinical practice and guidelines for electronic submissions.\nContribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros\nParticipate in the development of CRFs, edit check specifications, and data validation plans\nProvide review and/or author data transfer specifications for external vendor data\nCollaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals\nProvide review and/or author SOPs and/or Work Instructions related to statistical programming practices.\n\nQualifications\nHere at Cytel we want our employees to succeed, and we enable this success through consistent training, development and support. To be successful in this position you will have:\nAt a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred\n8+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies\nExceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment\nExtensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation\nExperience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities\nMust be able to work independently\nOutstanding communication skills (written and verbal) and strong leadership skills\nPreferred Qualifications (nice to have)\nPrior work experience with pharmacokinetic data and the neuroscience field,\nproficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)