Senior/Principal Statistical Programmer FSP (Remote)

Das ist der Job

This is an exciting time to be a part of this new program.

Darum lohnt es sich

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.

Responsibilities • Generate SDTM, ADaM specifications, datasets, reviewer\'s guides and define.xml files for multiple studies • Develop SAS/R programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs • Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs • Participate in overseeing CRO\'s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines • Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses • Understand and follow FDA regulations which affect the reporting of clinical trial data, including good clinical practice and guidelines for electronic submissions • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros • Participate in the development of CRFs, edit check specifications, and data validation plans • Provide review and/or author data transfer specifications for external vendor data • Collaborate with internal and external functions (e.g., CROs, software vendors, clinical development partners) to ensure meeting project timelines and goals • Provide review and/or author SOPs and/or work instructions related to statistical programming practices Qualifications • At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics; advanced degree preferred • 5+ 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 • Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment • Extensive applied experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities • Must be able to work independently • Outstanding communication skills (written and verbal) and strong leadership skills Overview Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you\'ll be at the heart of our client\'s innovation.

As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.

Position Overview The position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel.

We are looking for a highly experienced senior statistical programmer who will work on clinical development programs across 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.