Statistical Programmer II

Ora

1d • Remote

About The Position

At Ora, we are building the future of ophthalmic clinical research. As the world’s leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America.

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

Requirements

• 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.
• 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).

Nice To Haves

• BASE SAS and Advance SAS Certification or equivalent experience is preferred.

Responsibilities

• 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.
• Adherence to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.

Benefits

• Comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time
• 14 company paid holidays
• Competitive salaries
• 401K plan through Fidelity with company match.
• Adoption and fertility assistance provided
• 16 weeks paid Parental Leave
• Company Paid Life & Disability Insurance
• Remote & Wellness Reimbursement
• Employee Assistance Program
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level