Senior Statistical Programmer / Statistical Programmer II

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Lead role on projects, and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Essential Skills Required for this Senior Statistical Programmer role:

• Excellent analytical skills.

• Proficiency in: SAS, SDTM, CDISC, ADaM

• Extensive knowledge and understanding of the programming and reporting process with sound Statistical Programming (Clinical) experience within related industry (minimum 3.5+ years)

• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.

• Ability to learn new systems and function in an evolving technical environment.

• Strong project management skills.

• Strong organizational skills, ability to manage competing priorities, and flexibility to change.

• Attention to detail.

• Ability to successfully lead a global team.

• Work effectively in a quality-focused environment.

• Effective time management in order to meet daily metrics or team objectives.

• Show commitment to and perform consistently high quality work.

• Business/operational skills that include customer focus, commitment to quality management, and problem solving.

• Demonstrate commitment to refine quality processes.

• Good presentation skills.

• Good business awareness/business development skills (including financial awareness).

Senior Statistical Programmer Knowledge and Experience Required:

• Competent in written and oral English.

• Excellent communication skills.

Education:

• Educated to degree level in a relevant discipline and/or equivalent work experience.

Key Accountabilities / Responsibilities of this Role:

Project Management:

• Ability to fill Statistical Programming Lead role on projects

-Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
-Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
-Monitor project resourcing, project budgets, and identify changes in scope.

• Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

• Review statistical analysis plans and mock-shells.

• Review database set-up specifications.

• Interact with sponsors and internal stakeholders with regard to statistical programming issues.

• Assist project teams in the resolution of problems encountered in the conduct of their daily work.

Statistical Programming for Assigned Projects:

• Deliver best value and high quality service.

• Check own work in an ongoing way to ensure first-time quality.

• Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.

• Produce/QC dataset specifications and other process supporting documents and submission documentation.

• Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.

Training:

• Maintain and expand local and international regulatory knowledge within the clinical industry.

• Develop knowledge of SAS and processes/procedures within other Parexel functional areas.

• Provide relevant training and mentorship to staff and project teams.

General:

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.

• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.

• Proactively participate in and/or lead process/quality improvement initiatives.

• Provide consultancy to internal and external sponsors with regard to statistical programming tasks.

• Represent Parexel at sponsor marketing and technical meetings.

• Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Statistical Programmer II Job Profile Summary:

The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.

Skills Required for SP II level:

Excellent analytical skills.

Proficiency in SAS with sound Statistical Programming experience within a related environment.

Knowledge and understanding of the programming and reporting process.

Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.

Ability to learn new systems and function in an evolving technical environment.

Ability to manage competing priorities and flexibility to change.

Attention to detail.

Ability to successfully work as part of a global team.

Work effectively in a quality-focused environment.

Effective time management in order to meet daily metrics or team objectives.

Show commitment to and perform consistently high quality work.

Business/operational skills that include customer focus, commitment to quality management, and problem solving.

Knowledge and Experience:

Good clinical statistical programming skills and experience (2 years + experience).

Competent in written and oral English.

Good communication skills.

Education:

Educated to degree level in a relevant discipline and/or equivalent work experience.

Statistical Programmer II Key Accountabilities:

Project Management:

Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

Statistical Programming for Assigned Projects:

Deliver best value and high quality service.

Check own work in an ongoing way to ensure first-time quality.

Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.

Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.

Training:

Maintain and expand local and international regulatory knowledge within the clinical industry.

Develop knowledge of SAS and processes/procedures within other Parexel functional areas.

Provide relevant training and mentorship to staff and project teams as appropriate.

General:

Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.

Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.

Proactively participate in process/quality improvement initiatives.

Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).