Manager, Statistical Programming

Proclinical is currently recruiting for a Manager of Statistical Programming with a leading biopharmaceutical company located in Boston, MA. Successful candidate will implement statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses and out-sourced clinical trials, commercial requests and biostatistical ad-hoc analyses.

Job Responsibilities:

• Write SAS programs to implement statistical analyses (i.e., generating tables, listings, figures, and inferential statistical output) supporting regulatory requests, ISS/ISE analyses, commercial requests, biostatistical ad-hoc analysis.
• Review and validate CRO deliverables.
• Oversee programming related activities perform by CRO.
• Perform SAS programming using more complex techniques as SAS macro language, advanced data manipulation techniques, and statistical procedures (e.g., PROC GLM, PROC FREQ, PROC REPORT).
• Troubleshoot and provide quality review of complex SAS programs.
• Code SAS utility macros, write and implement test plans to support SAS macro development.
• Help solve critical issues requiring SAS expertise.
• Perform quality review on SAS programs generated by other statistical programmers and biostatisticians.
• Follow good programming practices and adequately documents programs.
• Act as an integral member of project team. Attend project team meetings, work with vendors, biostatisticians, data managers, and clinical research managers, as appropriate.
• Keep informed of SAS programming techniques as applied to clinical trials by reading relevant journals and/or attending courses/programming meetings.
• Understand and follows FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Participate on Submission Working Groups help providing technical support.
• Lead the development of data collection, analysis and reporting standards content and processes.

Skills and Requirements:

• BA/BS with 5+ years' relevant experience or an MS with 3+ years' experience.
• Good knowledge of SAS, including SAS macro language, data manipulation techniques, and statistical procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM).
• 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.
• Good analytical skills.
• Strong verbal and written communication skills.
• Ability to multitask and prioritize work.
• Ability to communicate technical concepts clearly and concisely to non-technical colleague.
• Capable of using Windows, Word, Excel.
• Knowledge of medical and statistical terminology.
• Familiarity with coding dictionaries.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Felix Hook (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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