Principal Statistical Programmer FSP

Cytel; Santa Fe (NM); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, providing expert SAS programming and leadership for SDTM/ADaM data submissions. You will operate with minimal supervision, driving technical solutions and directing project work within cross-functional teams.

You will ensure compliance with FDA/ICH regulations, contribute to regulatory submissions, and mentor other programmers while maintaining rigorous documentation and quality standards.

Formación

• MS in biostatistics or related field with 8+ years in pharma
• BS in biostatistics or related field with 10+ years in pharma
• Expert in SAS language, procedures, and options used in clinical trial reporting

Responsabilidades

• Provides technical and project management leadership in SAS programs and applications for complex trial data
• Creates, reviews and approves documentation to support data analysis and CDISC submission
• Leads compliance with SOPs and FDA/ICH/GCP regulations
• Participates in technical meetings with internal/external stakeholders (IS, CROs, Vendors, FDA/EMA)
• Performs QC of advanced SAS code and outputs
• Reviews Define.xml and creates reviewers guides for SDTM/ADaM datasets
• Maintains study documents per standard process
• Programs, tests and documents global utility programs and tools

Conocimientos

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independent work

Communication

Educación

MS in biostatistics

BS in biostatistics

Herramientas

SAS

Descripción del empleo

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 / Affidative 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.