Principal Statistical Programmer FSP
Principal Statistical Programmer FSP
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Principal Statistical Programmer FSP
Job Location: India
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Sponsordedicated
JOB DESCRIPTION
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 highquality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.
Responsibilities
As a Principal Statistical Programmer your responsibilities will include:
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:
JOB DESCRIPTION
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 highquality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.
Responsibilities
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 highquality 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 highquality and meet the prespecified 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
- 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)
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Employment Type
Full Time
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