The Principal Statistical Programmer oversees statistical programming for clinical trials, generates datasets and reports, and ensures high-quality deliverables while supporting regulatory submissions.
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
- 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
Top Skills
Adam
Cdisc
Define.Xml
R
SAS
Sdtm
Similar Jobs
Software • Analytics • Biotech
The Principal Statistical Programmer oversees statistical programming for clinical trials, ensuring quality deliverables, developing specifications, SAS programs, and collaborating with CROs. Requires experience in Biotech/Pharma and CDISC standards.
Top Skills:
GitJavaPythonRSASShinyUnix/Linux
Software • Analytics • Biotech
The Principal Statistical Programmer will independently manage statistical programming for clinical trials, overseeing CRO deliverables, generating datasets, and ensuring compliance with FDA regulations.
Top Skills:
JavaMarkdownPythonRSASShinyUnix/Linux
Software • Analytics • Biotech
The Principal Statistical Programmer will generate datasets and reports, oversee CRO's programming deliverables, and ensure compliance with FDA regulations, while collaborating with various teams in clinical trials.
Top Skills:
AdamCdiscGitJavaMarkdownPythonRSASSdtmShinyUnix/Linux
What you need to know about the Mumbai Tech Scene
From haggling for the best price at Chor Bazaar to the bustle of Crawford Market, the energy of Mumbai's traditional markets is a key part of the city's charm. And while these markets will always have their place, the city also boasts a thriving e-commerce scene, ranking among the largest in the region. Driven by online sales in everything from snacks to licensed sports merchandise to children's apparel, the local industry is worth billions, with companies actively recruiting to meet the demands of continued growth.
