Statistical Programmer II

POSITION TITLE: Statistical Programmer II

DEPARTMENT: Biostatistics

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

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.

What You’ll Do:

• 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.

What We Look For:

• Experience needed for the Role:
  • 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.

• Additional Skills and Attributes:
  • 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.

• Competencies and Personal Traits:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
    • IQ, EQ and SQ: 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.
    • Clear and Direct Communication, Feedback and Conflict Resolution: 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.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: 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.

What We Offer:

• Well Being : Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
• Financial : Competitive salaries along with a 401K plan through Fidelity with company match.
• Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
• Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
• Career Development Opportunities :Continued opportunities to grow and develop your career journey.
• Global Team : Opportunities to work with colleagues across the globe.
• Impact : 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. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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