Principal Statistical Programmer

Responsibilities :

• This position is responsible for the creation and validation of statistical programming deliverables, including compliant SDTM and AdaM datasets, all associated submission deliverables, and the tables, figures, and listings as required for the analysis and reporting of clinical trial data.
• Additional responsibilities include the QC of junior level programmer deliverables. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment.

Strong initiative and follow through are.

• Essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
• Manage study deliverables (single study), ensuring that timelines are met and expected quality is attained.
• Train and / or mentor junior level programmers.
• Liaise with Data Management and Biostatistics for database and dataset specifications, timelines, and quality requirements.

Create and validate SDTM and AdaM datasets and associated submission deliverables in compliance with published industry standards and project / study specific requirements.

Create and validate TFL output in compliance with study specific requirements. Receive, import, and verify the structure of external data.

Create and maintain supporting documentation. Assist in creation of automated, standard programming; SAS macros and stored procedures as required.

• Contribute to departmental process improvements; SOPs and Wis.
• Maintain professional currency through : Demonstrable expertise in SAS analysis and reporting programming. Demonstrable expertise with CDISC CDASH, SDTM, ADAM, DEFINE-XML, and / or controlled terminology.
• Implementation of standard clinical data solutions best practices from CRF design through data analysis and reporting.

Attendance and presentation at appropriate scientific meetings and conferences. Perform other duties as assigned.

Core Competencies, Knowledge and skill Requirements Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment;

honesty, integrity, and trust building behaviors in all dealings is essential and required.

Requirements :

Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.

Daily demonstrates a positive, 'can do' and service-oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy, Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.

• Ability to multi-task and shift priorities quickly while working under tight deadlines.
• Skilled in developing collaborative internal and external relationships. Required skill in the operation of standard office equipment including : fax machines, copy machines and other equipment as necessary.
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.

Ability to effectively communicate, collaborate and deliver an excellent work product in a fast paced, and rapidly growing dynamic company.

• or equivalent in computer science, mathematics, or life science. A minimum of years of relevant clinical research programming experience, years specifically in the pharmaceutical industry.
30+ days ago