[Hiring] Statistical Programmer II @Ora

Role Description

Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating SDTM datasets, analysis datasets, tables, listings, and figures for clinical trials.

• Perform assigned statistical programming required for clinical trial analysis and reporting.
• Work under the direction of senior statistical programmers in completing clinical trial programming tasks.
• Review the Statistical Analysis Plan in preparation for programming analyses.
• Apply appropriate statistical methods for data analysis.
• Assist in designing/developing SAS macros and other utilities to expedite SAS programming activities.
• Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request.
• Participate in statistical program validation and quality control activities, as assigned.
• Assist in development of SDTM aCRF and specifications; complete programming and validation of CDISC SDTM and ADaM datasets.
• Develop define.xml and create table of contents of programs for regulatory submissions.
• Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects.
• Program data cleaning checks, as necessary, to facilitate Data Management's data cleaning activities.
• Timely completion of assigned tasks within budgeted hours.
• Utilize the Infrastructure for project files of SAS datasets and SAS code.
• Ensure all programming activities and processes performed are conducted according to Ora’s standard procedures and/or sponsor requirements.
• Adhere to all aspects of Ora’s quality system.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
• Responsibilities may differ from the above based on the specific needs of the business.

Qualifications

• Bachelor's degree in computer science, statistics, or other related scientific field and two (2) to four (4) years of relevant professional experience; or an equivalent combination of relevant education and/or experience.
• Sound analytical skills, with the ability to process scientific and medical data.
• Proficient SAS programming skills required, with expert knowledge in SAS/Base, working knowledge in SAS/Stat and SAS Macros. Basic understanding of SAS/Graph.
• Experienced in manipulating and analyzing SAS data.

Requirements

• Ability to independently identify data issues, understand and present problems clearly, and implement effective and time-efficient solutions.
• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
• BASE SAS and Advance SAS Certification or equivalent experience is preferred.

Benefits

• Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Providing flexible PTO & unlimited sick time in addition to 14 company paid holidays.
• Competitive salaries along with a 401K plan through Fidelity with company match.
• Adoption and fertility assistance provided along with offering 16 weeks paid parental leave.
• Offering company paid life & disability insurance.
• Reimbursement to support your remote workspace and wellness purchases.
• Employee Assistance Program available for you and your family.
• Continued opportunities to grow and develop your career journey.
• Opportunities to work with colleagues across the globe.
• A chance to research new ophthalmic therapies that will impact patients across the globe.