Principal Statistical Programmer (Home Based)
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POST DATE 9/15/2016
END DATE 12/14/2016
JOB DESCRIPTIONThe Principal Statistical Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. In addition, the Principal Statistical Programmer will lead; liaise with sponsors, Data Operations Leads, and other functional areas as required. Further, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets. General areas of responsibility also includes: import/export programming specification development, test data creation and test data entry, import/export programming functional testing, as well as mapping specifications to support relevant data standards
- Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
- Provide oversight and guidance on multiple-trial programs, complex trials, and submission projects (including Integrated Summary of Safety or Efficacy).
- Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
- Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
- Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
- Monitor project resourcing, project budgets, and identify changes in scope.
- Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
- Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
- Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
- Maintain and expand local and international regulatory knowledge within the clinical industry.
- Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both PAREXEL and sponsors.
- Provide broad support, including advice on new technologies and industry technical standards (e.g. EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies, etc.) and their integration into Programming processes.
- Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
- Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.
- Create standard macros and applications to improve the efficiency of the department.
- Represent PAREXEL at sponsor marketing and technical meetings.
- Represent Statistical Programming on cross-functional technical initiatives.Qualifications
- Proficiency in SAS.
- Knowledge of the programming and reporting process.
- Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
- Ability to successfully work together with a ( virtual ) team (including international teams as required) as well as independently.
- Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
- Ability to negotiate and influence in order to achieve results.
- Business/Operational skills that include customer focus, commitment to quality management and problem solving.
- Good business awareness/business development skills (including financial awareness).
- Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
- Effective time management in order to meet daily metrics or team objectives.
- Show commitment to and perform consistently high quality work.
- Educated to degree level in a relevant discipline and/or equivalent work experience
- Competent in written and oral English.
- Excellent communication skills.
Minimum Work Experience
- Relevant Clinical Trial industry experience.
- Project leadership experience required.
- Proven record of leading a team and large scope of projects in a GRO, Technical, Clinical, Medical or Statistical environment. EEO DisclaimerPAREXEL complies with all applicable federal, state, and local laws prohibiting discrimination in employment. All qualified applicants will receive consideration for employment without regard to gender, age, race, color, religious creed, marital status, sexual orientation, national origin, ethnicity, ancestry, citizenship, genetic information, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.