Project Manager

3 weeks ago


Lake Forest, United States Mindlance Full time

Summary Author and/or provide input on statistical sections of clinical study documents including protocols, electronic case report forms, randomization plans, data transfer specifications, statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents. Drive TLF development and TLF reviews with programming and other relevant team members, determine analysis populations, validate key analysis results, and present final analysis results to key stakeholders Accountability for 5+ concurrent studies Represent the Statistics function in study team meetings

Qualification : Masters or PhD in Statistic s 3-5 years recent/related statistical experience within a pharmaceutical and/or medical device company, or similar organizatio n Experience with different clinical phase s Knowledge of clinical trial methodology and study desig n Study-level statistical expertis e Proficiency in SAS and knowledge of CDISC standard s Strong working knowledge of statistical data analysis and data management principle

s EE O:Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veteran

s. by Jobble

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