Location: Washington DC, DC
Employment Style: Any
Years of Experience: 6-10
Education Level: Bachelor's Degree
Job Title: Senior Statistical Programmer II - FSP
Department: Clinical Research Services
Reports to (title): Director, Statistical Programming
As member of the Functional Service Provider (FSP) group, and reporting to the Director of Statistical Programming, the main responsibilities of the Senior Statistical Programmer II will be to:
• Contribute to the development of a strong team of statistical programmers globally, by functionally managing programmers with respect to statistical programming strategy, deliverables, processes, and professional development.
• Represent Statistical Programming on multiple clinical project teams.
• Coordinate statistical programming activities of a study by managing project timelines, delegating assignments and scheduling of deliverables.
• Ensure high quality results and project milestones are achieved efficiently.
• Review and provide comments on the specifications for the clinical database and the statistical analysis plan.
• Review and provide comments on the specifications of the data required for submission.
• Design, develop and maintain programs that will produce and/or validate analysis datasets, tables, listing and figures.
• Develop and maintain standard database specifications and standard report specifications.
• Develop reusable standard programming code and applications that will improve efficiency and ensure quality.
• Understand, follow and ensure adherence to, all sponsor SOPs as well as any other relevant SOPs.
Role Specific Responsibilities:
• Serving as the Lead Programmer for one or more clinical research studies.
• Provide programming support to multiple clinical research studies.
• Producing and/or validating analysis datasets.
• Producing and/or validating tables, listings and figures.
• Developing and maintaining study specific database and report specifications based on CDISC standards.
• Developing and maintaining standard macros used across programs.
• Mentoring and training Statistical Programmers.
Qualifications and Experience:
• Minimum Education and Years of Experience: BSc with minimum 8 years or advanced degree with minimum 6 years in Computer Science, Statistics, Mathematics, or a related quantitative analytical field. Minimum 2 years experience in a technical leadership role.
• Minimum Requirements:
o Excellent analytical, technical, and computer skills.
o Expert programming ability using BASE/SAS, SAS/STAT, SAS MACROS, and SAS/GRAPH.
o Expert knowledge of SDTM and ADAM requirements.
o Advanced knowledge of medical terminology, clinical trial methodologies, and FDA/ICH regulations.
o Excellent verbal and written communication.
o Excellent interpersonal skills.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.
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