The Principal Statistical Programmer develops and validates SAS and R programs, SDTM and ADaM datasets, specifications, tables, listings, graphs, Define.xml files, and reviewer’s guides for clinical trials. The role supports regulatory submissions, clinical study reports, data validation, CRF and edit-check development, vendor data transfers, and CRO oversight. It requires extensive oncology expertise, independent ownership of multiple studies, compliance with FDA and CDISC standards, and collaboration across global clinical development teams.
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.
As a Principal Statistical Programmer, your responsibilities will include:
- 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
- 8+ 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
- Proficient in programming using analytical software such as SAS and R
- Extensive Oncology experience and in-depth knowledge
- Hands-on experience across the full spectrum of statistical programming activities, including but not limited to:
- SDTM and ADaM specification creation and review
- SDTM and ADaM dataset development
- TLF programming
- Define.xml and reviewer’s guide creation
- Skilled in developing macros tailored to project needs
- Demonstrated ability to work independently with minimal supervision from study or asset leads
- Strong sense of ownership and accountability for assigned tasks
- Effective communicator who proactively engages with the team
- Capable of offering process improvement suggestions to the study team
Active participation in programming team meetings and collaborative discussions
Additional Preferences:
- Prior experience working in a global team environment
- Familiarity with CDISC standards and regulatory submission requirements
- Experience supporting FDA, EMA, and PMDA submissions
- Ability to manage multiple studies simultaneously
- Strong documentation and organizational skills
Cytel Pune, Mahārāshtra, IND Office
Pune, India
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