Manager/Senior Manager of Statistical Programming

Qualifications:

• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 5+ years in a programming or statistical role
• At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs, including the coordination of large teams of internal and/or external programmers
• Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met
• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)
• Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs
• SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures
• Experience with R programming a plus
• Must be able to program defensively, check results, and consistently produce accurate outputs
• Knowledge of regulatory guidelines (FDA, EMA, ICH) relevant to clinical trials, statistics, and data handling, along with advanced knowledge of submission requirements and standards
• Experience in contributing to the review of statistical analysis plans and developing technical programming specifications
• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors
• NDA submission experience a plus
• Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders
• The ability to thrive in various situations, enthusiastically embracing organizational changes and evolving job demands
• Skills planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines under pressure
• Compensation:
• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work remotely or in Waltham, MA, is $146,000 to $161,000 for Manager and for Sr Manager $161,000-$187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.
• We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
• What We Offer:
• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.