As a member of Parexel’s Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and therapeutic areas, or choose to focus your career on working with a specific sponsor and gaining in depth knowledge of a specific therapeutic area and compound.
You will become a part of a team with an inherent breadth of knowledge and expertise in small, single center Investigator studies to multi-site, multi-national trials in Phases I to IV of clinical development, as well as observational studies. From initial planning meetings at the study design stage through to implementation and execution, our team of skilled statistical programmers will employ industry-accepted statistical tools and techniques, as well as innovative consulting, to provide the quality and efficiency of projects.
Parexel develops and delivers cost effective, high-quality training programs for those employees that are directly involved with sponsor functional partnerships to ensure that our statistical programmers can quickly step in to make significant contributions to the success of a study. In addition, you will receive the opportunity to shape your development through quarterly conversations with your manager. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
- Travel: Minimal
- Glassdoor Reviews and Company Rating
Check out the top traits we’re looking for and see if you have the right mix.
- Team player
"I have learned a great deal and developed my expertise. The management team here is open and honest and it is refreshing to be treated with a high degree of trust and flexibility. I have been fortunate to work on a wide variety of projects and partnerships and the work is always interesting."Richard – Principal Statistical Programmer
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Opportunity to learn and grow through a performance and development goal-setting program.
Work with industry leaders and subject matter experts.
Opportunity to work on a wide range of therapeutic areas and medical devices.
Company Name: Parexel International LLC
Position Title: Statistical Programmer II
Location: 275 Grove Street, Newton, MA 02466
Summary of Duties: 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. Fills lead statistical programming role on small, non-complex projects. Uses efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and quality control of low-medium complexity derived datasets, tables, figures, and data listings. Assists in the production and quality control of derived dataset specifications and other process supporting documents and submission documentation. Maintains local and international regulatory knowledge within the clinical industry. Utilizes knowledge of SAS and other processes and procedures within various PAREXEL functional areas. Provides relevant training and mentorship to staff and project teams. Maintains all supporting documentation for studies in accordance with SOPs and Guidelines to ensure traceability and regulatory compliance. Ensures compliance with SOPs and Guidelines, ICH-GCP, and any other applicable local and international regulations. Participates in internal and external audits and regulatory inspections. Participates in process and quality improvement initiatives. Assists in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Duties may be performed remotely.
Qualifications: Bachelor’s degree in Bioinformatics, Statistics, Mathematics, Biostatistics, Data Analytics, or related field, and three (3) years of experience as a Statistical Programmer, Clinical Programmer, Biostatistician, or other related role. Will accept a single degree or any combination of degrees, diplomas, professional credentials or employment experience determined to be equivalent by a qualified credential service. Three (3) years’ experience with: SAS; clinical programming and reporting process; clinical programming standard operating procedures (SOPs) and guidelines, ICH-GCP, and applicable local and international regulations, including 21 CFR Part 11, CDISC, and electronic submissions.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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