Associate Director of Statistical Programming/Biometrics - Caribou Biosciences, Inc.

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. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

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.  Additional tasks include determining resource needs; overseeing the performance of contract programmers, Contract Research Organizations, and other vendors; and assisting with recruiting efforts.  The scope of in-house deliverables for the department will include CDISC (SDTM and ADaM) data sets; tables, figures, and listings (TFLs) for clinical study reports (CSRs), development safety update reports (DSURs), investigator brochures, etc.; exploratory analyses and outputs for publications and internal data exploration; and listings and other deliverables to assist with data cleaning and review.  

In close collaboration with the Head of Biometrics, supporting statisticians, and clinicians, the Associate Director, Statistical Programming will also ensure that statistical analyses that support decision-making, publications, study reports, and regulatory submissions are delivered expeditiously and at a consistently high quality.

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

Nice-to-haves:

• Experience with alternative programming and mark-up languages (e.g. R, Python, XML) and/or data structures (e.g. XML, JSON) is desirable, but not essential

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. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance.
• 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)
• Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

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. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

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.

We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc.for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc.  will not be obligated to pay any referral or placement fee.