manager, statistics management Penfield seek partners profits:
$1 – 2 in keeping with yr
Reference:
activity-5968
Our patron is a biopharmaceutical business enterprise committed to getting to know, growing, and commercializing transformative therapeutics to treat a extensive spectrum of retinal illnesses. specializing in bringing new science to the design and manufacture of next–technology retinal drug treatments to prevent and treat the leading causes of blindness globally, this position is on-site on the enterprise’s headquarters in Palo Alto, CA, so nearby applicants are favored. The agency’s three lead product applicants are in section III with BLAs to comply with within the close to time period, so there is a key possibility here to play an critical function in submission hobby. presently they’re looking for a devoted and detail–oriented manager, information management to make contributions to database development, statistics fine oversight, and vendor coordination to make certain correct, compliant, and submission-prepared statistics. the precise candidate will carry sturdy fingers-on revel in and a collaborative attitude, running carefully with go–practical teams to pressure a success trial execution and regulatory submissions. help the design, development, and validation of scientific trial databases and digital Case file bureaucracy (eCRFs) on the have a look at level. Oversee statistics cleaning, query decision, and shipping of tremendous datasets to assist trial milestones and regulatory submissions. Collaborate with outside statistics control vendors to make sure well timed and excellent deliverables; song overall performance towards task timelines and pleasant standards. participate in the preparation, evaluate, and validation of submission-equipped datasets for regulatory filings (e.g., NDA, BLA, MAA). ensure compliance with industry standards and rules (GCP, FDA, EMA) and help in audit and inspection readiness. Coordinate with inner stakeholders including clinical Operations, Biostatistics, Regulatory Affairs, and IT to make sure smooth statistics integration and reporting. contribute to the implementation and optimization of scientific facts structures and tools (e.g., EDC, records assessment structures). Please have : Bachelor’s diploma in life Sciences, information technology, computer technology, or a related subject. 7+ years of enjoy in scientific information control inside the biotech, pharmaceutical, or CRO enterprise. revel in coping with have a look at–level data management activities and working with external vendors. Familiarity with medical information structures (e.g., Medidata RAVE, Oracle clinical, Veeva) and industry information standards (e.g., CDISC, SDTM). demonstrated experience assisting regulatory submissions is a plus. sturdy trouble–solving, organizational, and communique competencies. that is a seen function in a smaller corporation in which you’ll have the opportunity to have real impact in this meaningful field
