Principal Statistical Researcher

2 weeks ago

india beBeeStatistical Full time

Job Title: Senior Statistical AnalystAs a key member of our client's innovation team, you will be responsible for implementing reporting and analysis activities for Sponsor clinical trials.This role requires a high level of autonomy and ownership, with minimal supervision. You will track progress and provide expert technical support to team members.Your responsibilities include generating SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies; developing SAS programs which generate datasets, complex listings, tables and graphs; delivering high-quality statistical programming results; and participating in overseeing CRO's statistical programming deliverables.The ideal candidate will have a bachelor's degree in computer science, data science, mathematics or statistics major, and 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team.Candidates should possess exceptional SAS programming skills, expertise in CDISC standards, medical terminology, clinical trial methodologies and FDA/ICH regulation. Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities is also essential.A prior work experience with pharmacokinetic data and the neuroscience field, proficiency in languages or tools other than SAS (e.g., R, Python, Java) are considered desirable qualities.

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