Senior Statistical Programming Analyst (Medical Devices)

We are looking for

• Develop complex analysis datasets, specifications, and summary output (tables, listings, or graphs) for inclusion in clinical reports or presentations, Create complex programs that meet regulatory and company standards to permit efficient programming, reporting, and review, utilizing statistical programming languages (e.g., SAS).
• Review and validate statistical programs and ensure that all appropriate program validation documentation to meet regulatory and company standards are consistently structured to permit efficient programming, reporting, and review Perform complex analysis in response to data requests in collaboration with designated statistician.
• Collaborate with CDM (Clinical Data Management) and designated statistician to review draft CRFs (Case Report Forms), database specifications, and perform edit checks.

• Proven expertise in interfacing MS Office Suite with SAS.
• Good written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills.
• Full understanding and knowledge relevant to statistical programming.
• Full understanding and knowledge of regulatory guidelines (e.g., Google Cloud Platform, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device setting.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Good leadership skills and ability to influence change.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects.
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.

• Bachelor's Degree or equivalent in Statistics, Mathematics, Computer Science or related field, 5+ years of previous statistical programming (e.g., SAS) experience in clinical trials within a pharmaceutical/medical device industry Required.
• Master's Degree or equivalent in Statistics, 2-3 years of previous statistical programming (e.g., SAS) experience in clinical trials within a pharmaceutical/medical device industry Required.