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 Programmer, Clinical Data Standards proactively participates in the development of data and reporting standards in support of the client’s portfolio of clinical trials and ensures conformance to CDISC standards and industry best practices. This role supports the development of strategy and framework for governance of standards and actively engages in deployment of next generation process and technology.

As a Principal Statistical Programmer, your responsibilities will include:

Support development of documentation and specifications including business guidance’s for standard practice for dataset mapping, SDTM, ADaM, and TLFs for study reporting efforts, and associated tool instruction guidelines

Contribute to development and review of (draft/existing) SDTM, ADaM, and TLF Standard content to ensure complete with sufficient content and details for macro implementation

Managing the development and maintenance of data management processes and tools

Responsible for providing standards guidance and support to the trial team

Writing detailed programming specification for standard rules including creation of standard computational algorithm documents to enhance content in ADaM metadata

Development of new standard TLF shells specification and associated annotation of the TLFs with ADaM variables

Creation of analysis results metadata (ARM) for TLF standards

Work in Pinnacle 21 to test metadata use for define.xml. Review standards metadata and support development of additional standard metadata for define.xml (VLM and derivation logic)

Understand CDISC standards (including those used for complex data such as RWD, GF and CP) changes and guidance’s to align when developing business guidance’s and documentation in support of study teams

Develop mappings from RWD to SDTM to extend the CDISC mappings

Communicate ongoing standard development activities across the organization

Core Elements for this role:

Knowledge of the pharmaceutical industry, and overall drug development process with expertise in the cross-functional interfaces with stakeholders e.g., Statistics, Data Management, Regulatory functions

Strong detail-oriented written communication skills to organize content and explain technical content in the documentation and business guidance.

Strong oral communication skills to discuss technical content and in non-technical terms.

Knowledge ofthe pharmaceutical industry, and overall drug development process with expertise in the cross-functional interfaces with stakeholders e.g., Statistics, Data Management, and Regulatory functions.

Strong collaborative skills and ability to work with a cross-functional team.

Knowledge of GXP, FDA, and ICH regulations and industry standards applicable to the design, and analysis of clinical trials and regulatory submissions.

Knowledge of technical and programming methods.

SAS Programming skills to test and verify examples, and view and manipulate SAS datasets.

Strong CDISC knowledge including data mapping strategies with compliance in regulatory submission space.

Robust knowledge in Pinnacle 21 (Community and Enterprise) processes and define creation including reviewers’ guide and annotated CRF to support submissions.

Knowledge of complex data such as RWD, genomics, and cell phenotyping is desired

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

Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation

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

Must be able to work independently

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

Preferred Qualifications (nice to have)

Prior work experience with pharmacokinetic data and the neuroscience field,

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

Cytel Inc. is an Equal Employment / Affirmative 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.