Cytel

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.&nbsp; 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.
As a Principal Statistical Programmer, your responsibilities will include:
<ul>
<li>Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies</li>
<li>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</li>
<li>Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs</li>
<li>Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines</li>
<li>Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses</li>
<li>Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.</li>
<li>Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros</li>
<li>Participate in the development of CRFs, edit check specifications, and data validation plans</li>
<li>Provide review and/or author data transfer specifications for external vendor data</li>
<li>Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals</li>
<li>Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices</li>
</ul>
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:
<ul>
<li>At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred</li>
<li>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</li>
<li>Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment</li>
<li>Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation</li>
<li>Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities</li>
<li>Must be able to work independently</li>
<li>Outstanding communication skills (written and verbal) and strong leadership skills</li>
</ul>
Preferred Qualifications (nice to have)
<ul>
<li>Prior work experience with pharmacokinetic data and the neuroscience field,</li>
<li>proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)</li>
</ul>
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Principal Statistical Programmer (FSP Remote)

Principal Statistical Programmer (FSP Remote)

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