Statistical Programmer II

Summary

Ora is a full-service ophthalmic drug and device development firm supporting clinical research and regulatory submissions. The Statistical Programmer II provides statistical programming support for clinical trials, including developing and validating SDTM and ADaM datasets, producing tables, listings, and figures, and supporting data analysis and quality control activities.

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

Skills

• 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)
• Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work
• Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy
• Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again
• Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth
• Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see
• BASE SAS and Advance SAS Certification or equivalent experience is preferred

Qualifications

Must Haves

• 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)
• Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work
• Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy
• Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again
• Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth
• Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see

Nice to Haves

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

Benefits

• Comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO and unlimited sick time, in addition to 14 company paid holidays.
• A 401K plan through Fidelity with company match.
• Adoption and fertility assistance.
• 16 weeks paid Parental Leave.
• Company Paid Life & Disability Insurance.
• Remote workspace and wellness purchases reimbursement.
• Employee Assistance Program through New Directions for employees and their families.
• 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.
• Benefit eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Per diem workforce is eligible for Medical and Dental coverage after 6 months of service and working an average of 30 hours per week.