Director of Statistical Programming
- Employer
- Inozyme Pharma
- Location
- Boston, MA
- Start date
- Feb 3, 2025
View more categoriesView less categories
- Discipline
- Information Technology, Bioinformatics
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
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:
- 10+ years statistical programming experience in the CRO or Pharmaceutical Industry.
- 7+ years people and/or project management experience in the CRO or Pharmaceutical Industry
- BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree
- Advanced SAS programming skills in a clinical and statistical data environment across multiple therapeutic areas.
- Familiarity with validation tools, Pinnacle 21.
- Solid understanding of data collection and database concepts including data collection processes in clinical trials.
- Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
- Experience in submissions to regulatory authorities.
- Thorough understanding of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.
- Thorough understanding of industry standards such as CDISC data standards and controlled terminology, FDA guidance such as 21 CRF Part 11 and data standard requirements and ICH.
- Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment.
- Strong project management skills.
- Skilled in resolving issues, suggesting process improvements, and effectively completing them.
- Excellent verbal and written communication skills in a global environment.
- Proven ability to work with cross-functional teams, specifically Data Management, Biostatistics, Clinical Operations, Pharmacovigilance and Medical Affairs to initiate, lead, and implement new initiatives and process improvements.
Company
We are one energized Team, developing unique pathways to realize possibilities for patients without treatment options.
Rare Patients.
Rare Solutions.
- Website
- http://www.inozyme.com/
- Location
-
321 Summer St
Suite #400
Boston
Massachusetts
02210
United States
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