The Principal Statistical Programmer will independently manage clinical trial reporting activities, including the generation of SDTM and ADaM datasets and complex statistical outputs. They will also oversee CRO programming deliverables and ensure compliance with FDA regulations and clinical development standards.
Sponsor-dedicated:
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. This is an exciting time to be a part of this new program.
Position Overview:
This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. 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.
Responsibilities
As a Principal Statistical Programmer, your responsibilities will include:
Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
Develop SAS 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. 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 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, etc.) to ensure meeting project timelines and goals
Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
Qualifications
Here 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:
At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
7+ 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 of 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
Preferred Qualifications (nice to have)
Prior work experience with pharmacokinetic data and the neuroscience field,
proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)
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