Principal Statistical Programmer FSP

Cytel; Dover (DE); On-site; USD 150,000 - 210,000; Full time

Job summary

Cytel Inc. is seeking a Principal Statistical Programmer to work embedded with a major pharmaceutical client. You will lead SAS programming for complex clinical trial analyses and support regulatory submissions with minimal supervision.

Qualifications include an MS or BS in biostatistics with 8+ or 10+ years in pharma, expert SDTM/ADaM knowledge, Define.xml review, and strong communication. This role offers independent ownership and collaboration across CROs, FDA interactions, and internal teams.

Qualifications

• MS in biostatistics or related field with 8+ years in pharma
• BS in biostatistics or related field with 10+ years in pharma
• Exceptional SAS programming skills and SDTM/ADaM expertise
• CDISC standards, regulatory submissions experience, FDA/ICH familiarity
• Ability to work independently and lead projects

Responsibilities

• Leads SAS programming for complex trial analyses (Tables, Listings, Figures) and SDTM/ADaM datasets
• Develops and reviews documentation to support data analysis and CDISC submissions
• Ensures compliance with SOPs and regulatory regulations (FDA/ICH)
• Leads technical meetings with internal/external stakeholders (CROs, vendors, FDA/EMA)
• Performs QC of SAS code and reviews Define.xml and reviewer guides
• Maintains study documents and develops global utility programs

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH

Regulatory submissions

Leadership

Independent work

Education

MS in biostatistics

BS in biostatistics

Tools

SAS

Job description

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:

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. In addition, the Principal fluently and routinely briefs management on accomplishments, status, and issues under their own initiatives, as well as being a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer.

As a Principal Statistical Programmer, your responsibilities will include:

• Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor

• Provides technical and project management leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission

• Provides leadership to ensure compliance with company SOP'S and FDA/ICH/GCP regulations

• Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects with significant consequences and impact

• Performs quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers

• Performs review on define.xml and create reviewers guide for SDTM and/or ADaM datasets

• Review, maintain study documents per standard process

• Program, test, and document global utility programs and tools in accordance with standards and validation procedures

• Perform other duties as assigned

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:

• MS in biostatistics or a related field, with 8+ years of experience in pharmaceutical industry, or BS in biostatistics or a related field, with 10+ years of experience in pharmaceutical industry,

• 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

• Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH

• Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities

• Must be able to work independently

• Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively

• Outstanding communication skills (written and verbal) and strong leadership skills

• Excellent and transparent communication skills and ability to influence across multiple functions

• Experience with BLAs, MAAs and other regulatory submissions is a plus

Cytel Inc. is an Equal Employment / Assertive Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.