What are the responsibilities and job description for the Director of Statistical Programming position at Inozyme Pharma?
Position Overview :
Responsible for overseeing statistical programming activities for multiple clinical studies and performing quality review of CRO / Vendor SAS programs and deliverables. The individual will also perform programming analyses to generate ad-hoc requests for publications, presentations and responses to regulatory agencies requests.
Reporting Relationship : This role will report into the VP, Biomtetrics
About Inozyme Pharma :
Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL).
Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases.
Essential Duties and Responsibilities :
- Oversee CROs or Programming vendors to ensure programming high-quality deliverables.
- Review CRO / Vendor deliverables consisting of SDTM and ADaM specifications, P21 validation reports (or equivalent), SDTM and ADaM Reviewer’s Guides, aCRFs, Define.xml files, analysis metadata report and executable programs for CRT packages.
- Develop and validate programs that generate SDTM and ADaM datasets, tables, listings, figures (TLF) in response to regulatory agencies requests, publication requests, and ad-hoc analyses.
- Program, or oversee programming of, quality review checks and reports for use by Clinical Data Managers, Medical Monitors and other study team members.
- Review and provide input into data acquisition and collection strategies / databases (to ensure CDISC compliance) and Statistical Analysis Plans with corresponding TLF shells.
- Collaborating across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications, and computing environment support.
- Evaluating, developing, revising, implementing, and ensuring compliance with functional guidelines, policies, and SOPs.
- Submission planning for BLAs and keeping abreast in changing regulatory data standard requirements.
Desired Skills & Experience :
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