Statistical Programmer, Biometrics

PREFERRED EDUCATION:

• Bachelor’s or higher degree in Statistics, Computer Science, Mathematics, Engineering, or a related discipline.

PREFERRED EXPERIENCE:

• At least 2-4 years of experience of clinical trial programming experience in the biotechnology, pharmaceutical, or health-related industry.
• Excellent technical skills; familiarity with coding dictionaries.
• Experience and in-depth knowledge of CDISC standards, including ADaM, and controlled terminologies.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to communicate technical concepts clearly and concisely to non-technical colleagues.
• Strong organizational skills, attention to detail, and self-motivated.
• Vendor management experience.
• Experience in creating all components of a submission package.
• Team player, with the ability to work successfully across functions.

EQUAL OPPORTUNITY EMPLOYER/PROTECTED VETERANS/INDIVIDUALS WITH DISABILITIES

Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.

PURPOSE:

The Statistical Programmer, Biometrics serves as the programming lead of one or more studies and provides leadership and support to project teams on all programming matters. The Principal Statistical Programmer will work with the team to deliver study milestones from start-up to regulatory submission and approval and collaborate with the clinical team to ensure quality and timely delivery of data analysis for in-house and outsourced clinical trials.

KEY ROLES AND RESPONSIBILITIES:

• Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. is a plus.
• Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus.
• Ability to work on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player, and growth mindset.
• Act as an integral member of the project team. Attend project team meetings, work with Biometrics vendor, biostatistician, data manager, medical lead, clinical trial manager, and other functions to meet project deliverables and timelines.
• Manage all programming activities within a study, including timeline and resource planning.
• Lead or support the programming team and Biometrics vendors to produce ADaM datasets, TFLs, and supporting submission documents.
• Understands and follows FDA regulations which affect the reporting of clinical trial data.
• Participates in cross-functional initiatives representing Statistical Programming.
• Provide review and input to study documents and processes (such as Statistical Analysis Plans, eCRFs, SOPs, etc.).
• Develop and/or contribute to data collection, analysis, and reporting standards content and processes.
• Problem-solving and innovative skills that demonstrate initiative and motivation.
• Ability to work on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player, and growth mindset.
• Problem-solving and innovative skills that demonstrate initiative and motivation.