Head of Statistical Programming

Clinical        ·       New York, NY       ·       Full time

Job Summary

The Head of Statistical Programming will be responsible for statistical programming deliverables across development programs to work as a member of an integrated team translating Kallyope’s cutting-edge biology on the gut and gut-brain axis to transformational therapeutics. The successful candidate will function as the lead programmer for the function and across clinical development programs, and may supervise junior statistical programmers in-house and at CROs. This position reports into the Head of Biometrics. Kallyope is based in New York City, but this role can also be remote in the United States, preferable in the East Coast time zone.

Key Responsibilities

• Oversee CRO’s statistical programming deliverables for multiple clinical studies to ensure they are high-quality and meet the pre-specified timelines
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs
• Provide technical leadership in SAS programs and applications to report clinical trial data and for submissions of data in CDISC format
• Generate SDTM domains, ADaM datasets, and define.xml files
• Generate tables, figures, and listings as described in statistical analysis plans
• Develop quality control processes for SAS programing and execute for regulatory reporting, publications, and press releases
• Provide statistical programming support to exploratory analyses both internally and in response to regulatory agencies’ ad-hoc requests
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Define and maintain data repository folder contents associated with statistical programming
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc) to ensure meeting project timelines and goals
• Oversee statistical programming contractors and mentor junior team members

Qualifications And Education Requirements

• BS, MS, or PhD (or equivalent degree) with 10+ years of relevant work experience in Biotech, Pharma, Clinical Research Organizations, or other relevant organizations
• Mastery of SAS language and procedures commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations
• Experience working with CROs, vendors, and relationship management preferred
• Outstanding communication skills (verbal and written)
• Ability to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment

About Kallyope:

Kallyope is a clinical-stage NYC-based biotechnology company focused on the gut-brain axis.  The company, founded in 2015 by Tom Maniatis, Richard Axel, and Charles Zuker, leverages leading technologies to map the hormonal and neural circuitry between the gut and other organs, including the brain, and translate new discoveries into novel therapeutics.  Our cross-disciplinary biotechnology team has built a platform integrating single cell and single nucleus sequencing, computational biology, neural imaging, cellular and molecular biology, and human genetics to provide an understanding of gut and gut-brain biology which, when coupled with our deep drug discovery expertise, will lead to therapeutics in multiple areas of high unmet need.  The Company has two lead programs in clinical development, one targeting metabolic circuits for diabetes and obesity, and the other focused on restoration of GI barrier function for IBD and other disorders associated with a defective barrier.   The company has raised $479 M in 4 rounds of funding from several leading biotech investors.  For more details, see https://kallyope.com. 

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