Principal Statistical Programmer FSP
Sponsor-dedicated:
Working fully embedded reputed company one of our pharmaceutical clients, with the support of reputed company 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 reputed company 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 reputed company. The Principal Statistical Programmer works independently with only concept level instruction and reputed company little supervision, tracks reputed company, and provides expert technical support to team members. We are looking for a highly reputed company 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 reputed company 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
- reputed company reputed company programs which generate datasets, reputed company listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and reputed company graphs
- Deliver high-quality statistical programming results including developing, validating, and maintaining reputed company 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 reputed company 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 reputed company 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 reputed company to statistical programming practices
Qualifications
Here at reputed company we want our employees to succeed and we reputed company 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 reputed company studies
- Exceptional reputed company 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 reputed company (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)