Statistical Programmer 2

Senior Clinical Programmer Analyst will provide statistical programming and clinical expertise in the production of SDTM and AdaM domains, tabulations, graphics, and listings from clinical trial data. Prepare, document and test required programs and ensure programming code meet regulatory and company standards. Perform quality assurance procedures on work performed by others. Support of production activities, assist in the trainings for new employees.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Provides data to clients (internal and external) in functional format by:

• Creating and executing SAS edit check programs
• Validating edit check programs using standard validation practices and processes
• Developing SAS programs that convert data from EDC to protocol-specific SAS datasets in accordance with customer specifications
• Assist with the creation of SAS-related project programming and validation documentation
• Assist with the creation of SAS macro and format libraries

Ensures the quality of our client's data and data export by

• Reviewing and approving User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents
• Developing and implementing new CDM systems and enhancements to current CDM systems
• Understand, create, and communicate information about creating CDISC-compliant datasets
• Create documentation related to the generation of customer specific SAS datasets
• Maintain the SAS environment by providing assistance in SAS installation, updates, and maintenance
• Assist the Study Quality Representative in the testing of protocol specific SAS conversion programs

Ensures project timelines as they relate to Clinical Data Management operations by

• Assessing and assigning target dates for project timelines in conjunction with manager
• Adhering to target dates for project timelines
• Communicating any changes in target date to appropriate personnel including
• Project Manager Keeping department head informed of current issues
• Maintains departmental productivity and identifies opportunities for greater departmental efficiencies and quality by:
• Coordinating activities of the Clinical Programming department with related activities of other departments (operations programming, study QA, PM and DM) to ensure efficiency
• Evaluating current procedures and work instructions for accomplishing department objectives in order to develop and implement improved procedures
• Assisting the training department with the development and maintenance of Clinical Programming training materials

Secondary Responsibilities

Contributes to team effort by:

• Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned and deemed necessary
• Maintains Technical Knowledge by:
• Attending and participating in applicable company sponsored training
• Maintains Quality Service and Departmental Standards by:
• Reading, understanding and adhering to organizational Standard Operating Procedures (SOP) Assisting in establishing and enforcing departmental standards Reviewing and providing recommendations to management on operational procedures, and participating in process improvement initiatives

EDUCATION AND EXPERIENCE REQUIRED:

Education

• Bachelors degree in computer science, design or related field required
• Educational background in human-computer interaction, usability, user-centered design, user experience, information design, applied psychology, cognitive science, human factors, informatics, computer science, or other design/applied science fields is a plus.

Experience

• 6+ Years of experience, SAS programming experience in pharmaceutical related industry - Required
• 5+ Years of experience, Experience working with CDISC, SQL, and Relational Databases Required
• 3+ Years of experience, Understanding of database organization and how to extract data to generate listings and reports- Required

PREFERRED SKILLS:

• Ability to work in group setting and independently; ability to adjust to changing priorities
• Excellent attention to detail and orientation toward meticulous work
• Strong interpersonal and communication skills, both verbal and written
• Strong documentation and organizational skills
• Ability to project and maintain a professional and positive attitude

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:

Full Time, Permanent

COMMITMENTS:

• Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
• Willing to work in shifts as and when needed.

DISCLAIMER:

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.