This position will be comprised primarily of 4 discrete, but interlinked, components- 1) support to the clinical teams on key elements relating to Data Management & Stat Programming during the study planning and set up phases and participating in the selection of vendors/CROs for DM & SP activities 2) oversight and management of DM & SP providers through the entire study set up, conduct and reporting phases 3) with guidance from medical and statistical colleagues produce ad hoc data reports, graphical representations etc. as needed to support internal decision making, regulatory submissions, publications etc. and 4) help guide BioAge as it begins to build its own internal clinical data and programming environment consistent with the needs and growth of the company.
Develops systems for organizing data to analyze, identify and report data and trends, and mentors junior staff to develop these skills
Support data management by reviewing protocols for cross-project consistency and working with vendors for identifying standard case report form modules to meet objectives
Develops, reviews and/or approves data review and quality plans
Provides early strategic input into protocol design focused on data management and statistical programming elements
Primary statistical programming and data management contact for projects that have been contracted with contract research organizations, as well as internal projects
Selects, develops and evaluates personnel to ensure the efficient operation of the function
Directs programming of data outputs using SAS
Drives the design of patient profiles in collaboration with Clinical Operations and Medical Sciences
Directs the implementation of clinical systems including central laboratory data, site payments systems/vendors, eTMF systems, clinical dashboards, and IVR systems
Directs SDTM and ADaM dataset planning for clinical studies
Supports DSUR and IB data outputs
Supports DMC data output planning, validation, and reviews
And Required Skills
Bachelor’s Degree in Statistics, Mathematics, Computer Science or related field
10 + years’ experience in drug development
Expertise in SAS programming environment
Familiarity with clinical database systems, eCRF design and interactive response systems
Thorough understanding of clinical data standards (CDISC) and FDA required data sets for clinical data submissions
Demonstrates leadership skills in a team environment
Supports department infrastructure, including development and oversight of management policies, SOP development, and strategic planning
Experience in oversight and mentoring of more junior
BioAge offers a comprehensive compensation package, as well as generous paid time off in addition to company-observed holidays. We provide medical, dental, and vision insurance, along with a 401(k) retirement savings plan which includes matching employer contributions. We also pride ourselves in giving employees many opportunities for career development including a generous annual budget for continued learning, a direct and open-door environment, and a dedication to training and skill development.
BioAge is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. BioAge prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. BioAge conforms to the spirit as well as to the letter of all applicable laws and regulations.