- Reviews and validates CRO deliverables
- Oversees programming-related activities performed by CRO
- Supports and manages regulatory compliant Clinical Data Repository and biometrics programming environment
- Writes or reviews SAS programs to implement statistical analyses (i.e., generating tables, listings, figures, and inferential statistical outputs) supporting regulatory requests, IB/DSUR/PBRER analyses, ISS/ISE analyses, medical affairs requests, ad-hoc analyses and more
- Supports or oversees creation of SAS utility macros; writes and implements test plans to support SAS macro development as needed
- Performs quality review on SAS programs generated by other statistical programmers and biostatisticians
- Follows good programming practices and adequately document programs
- Attends project team meetings, works with vendors, biostatisticians, data managers, and clinical research managers, as appropriate
- Understands and follows FDA regulations including good clinical practice and guidelines for electronic submissions
- Leads the development of data collection, analysis and reporting standards and processes
- Provides mentorship and support to junior level programmers
- B.A. / B.S. / M.S. with 3+ years relevant experience
- QC experience working on NDA/BLA/MAA development and submissions
- Excellent knowledge of SAS, including SAS macro language and procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM)
- Experience managing a CRO
- Excellent knowledge of pharmaceutical standard initiatives such as CDISC, ADAM, SDTM, and CDASH
- Strong organizational skills, attention to detail and the ability to learn technical and clinical aspects of a clinical trial
- Ability to jump between multiple clinical trials/protocols.
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Statistical Programming Consultant - Cambridge, United States - Beacon Hill Life Sciences - Boston
Description
Job Description
Job DescriptionResponsibilities
Qualifications
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Company Description
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.\r\r
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: \r
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Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.
