Principal Statistical Programmer FSP

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 program.
  Position Overview: 
  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. This specific role will have a specific focus on secondary evaluation of data from clinical studies and projects, analyses for Health Technology Assessment (HTA), publications, exploratory analyses and other purposes.
 

As a Principal Statistical Programmer, your responsibilities might include: 

 

• Generate analysis dataset 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 potentially R) programs tailored to clinical development programs’ needs
• Program outputs required for HTA dossiers, publications, health economics, exploratory  purposes etc.
• Ability to use and understand data structures (CDISC or non-CDISC) from legacy projects and process such data them using SAS.
• Understand and follow regulatory regulations. 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
• 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

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 (10+ years preferred) 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 using legacy (non-CDISC) data structures is desirable
• Experience supporting regulatory submissions is a plus; experience supporting HTA dossiers, publications, adhoc analyses etc. is desirable.
• Must be able to work independently
• Outstanding communication skills (written and verbal) and strong leadership skills

Preferred Qualifications (nice to have)

• Proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)