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
Qualifications
B.A. / B.S. with 7+ years relevant experience or an M.S. with 5+ years' experience
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
Knowledge of medical and statistical terminology
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.
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Company Profile:
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