Associate Director of Statistical Programming/Biometrics

Associate Director of Statistical Programming/Biometrics

Hybrid, Remote

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases.

The role of the Associate Director, Statistical Programming is to help establish and maintain the Statistical Programming function, which will involve helping to qualify an in-house statistical computing environment, developing and maintaining SOPs and processes for deliverables, developing and maintaining tools (e.g. macros) to assist with those deliverables, and conducting the hands-on work associated with those deliverables.

Responsibilities:

• Oversee, manage, and/or perform internal statistical programming activities including:
  • Planned TFLs for Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), Investigator Brochures (IBs), etc.
  • Exploratory analyses for publications, regulatory responses, and internal decision making
  • Data validation and consistency checks and data listings
• Establish and maintain processes, tools, and standards relating to the production of all programmed deliverables (e.g. CDISC-compliant data sets and TFLs and data packages for regulatory submissions)
• Manage budgets, resource needs, and resourcing strategies for the function
• Manage and mentor contract statistical programmers
• Develop processes and tools to drive efficiency and quality
• Work with statisticians and study team members to determine project needs and priorities

Qualifications:

• Bachelor’s or Master’s degree or equivalent in a technical discipline such as Mathematics, Statistics, Computer Science or Life Sciences
• At least 8 years of experience with SAS programming in the pharmaceutical, biotech, or CRO industry
• Advanced SAS programming skills including SAS/BASE, SAS/Macro, SAS/SQL and plotting procedures
• Advanced knowledge and understanding of CDISC (SDTM, ADaM, define.xml) standards and implementations
• Excellent written and verbal communication skills
• A proven ability to solve problems working both independently and in teams

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $185,000 to $200,000 - This represents the present low and high end of the Company’s pay range for this position.
• Generous paid vacation time, in addition to company-observed holidays and floating holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

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