Principal Statistical Programmer Fsp

**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.

ShortDescriptionStr

Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.

**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) InternalQualificationsStr

**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) InternalResponsibilitiesStr

**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 c