Principal Statistical Programmer

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development

**Summary of Job Responsibilities**:

- Providing significant technical expertise for statistical programming in all phases of programming support, developing automated reports and preparation of submission data standard packages.
- Supporting statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects.
- Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures),
- Design and maintenance of statistical datasets that support multiple stakeholder groups.
- Serving as key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.
- Being able to serve as statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocol if/when called upon.
- Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.
- Maintaining and managing a project plan including resource forecasting.
- Coordinating the activities of the supplier’s programming team; and interacting with client statistical programmers
- Utilizing strong project management skills and ability to engage key stakeholders; leadership at a protocol level; determining approach and ensuring consistency, and directing development of others when opportunities arise.
- Designing and developing complex programming algorithms.
- Comprehending analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
- Utilizing expertise in CDISC and ADaM standards.
- Statistical programming for early and late stage clinical trials which can include both planned and ad-hoc needs.
- Enriched / Post Processed Datasets (individual or integrated).
- ADaM datasets (individual or integrated)
- Protocol and therapeutic area specific tables, listings, and figures (individual or integrated).
- Programming documentation following SOPs.

**Qualifications and Experience**:

- Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
- Minimum 10 years of SAS programming experience supporting clinical trials in the Pharmaceutical & Biotech industry.
- 3+ years of study lead experience working with cross functional teams, including leading programming teams.
- Strong experience in QCing and validating work of other programmers, preferably outsourced work.
- Strong SAS data manipulation, analysis and reporting skills
- with strong output programming experience
- Strong proficiency implementing the latest CDISC SDTM / ADaM standards.
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
- Submissions experience utilizing define.xml and other submission documents.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
- Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law._