Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
Principal Statistical Programmer, North America
Location
Arizona + 4 moreAll locations: Arizona, California, Maine, Ohio, Rhode Island
Posted
22 days ago
Salary
Not specified
Bachelor DegreeExperience acceptedEnglish
Job Description
• Uses R, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications
• Works to ensure that outputs meet quality standards and project requirements
• Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings
• Keeps project team members informed of programming progress and issues requiring their attention
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements
• Anticipates and addresses potential programming issues
• Conducts effective internal meetings (appropriate in format, frequency and attendance)
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business
• Accountable for on-time delivery across concurrent programming deliverables
• Acts as the lead statistical programmer
• Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements
Job Requirements
- Previous Industry Experience within R is required
- Must be eligible to work within North America without Sponsorship
- Undergraduate degree, preferably in a scientific or statistical discipline
- Extensive programming experience in SAS and R or other required software, preferably in a clinical trial environment
- Knowledge and experience in the use of CDISC Standards for regulatory agency requirements
- Experience in submissions to a regulatory agency preferred
- Experience in mentoring others in clinical trial process and CDISC Standards
- Excellent written and verbal communication skills
- Ability to read, write, speak and understand English.
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time