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Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a global pharmaceutical client. You will implement reporting and analysis activities, lead SDTM/ADaM development, and oversee CRO programming to ensure high-quality deliverables.

You will contribute to regulatory submissions, CSRs, and publications while applying FDA regulations and good clinical practice. Strong SAS/R skills and extensive biotech/pharma experience are essential.

Qualifications

• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills with expertise in SDTM/ADaM specifications.
• Bachelor's degree in computer science, data science, mathematics, or statistics.

Responsibilities

• Develop SAS programs to generate datasets, listings, tables, and graphs for clinical studies.
• Create and maintain SDTM/ADaM specifications, define.xml, and reviewer’s guides.
• Review CRO deliverables to ensure quality and timelines across studies.
• Support clinical study reports, regulatory submissions, and exploratory analyses.
• Adhere to FDA regulations, GCP, and electronic submission guidelines.

Skills

SAS programming

R programming

Statistical programming

FDA regulations knowledge

CRO oversight

Education

Bachelor's degree in Computer Science or Statistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Senior/Principal Statistical Programmer SAS + R (Remote)

**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.

• 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

**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