About this role
This role provides statistical leadership for clinical trials, including designing analyses, developing protocols and statistical analysis plans, and delivering high-quality outputs. The manager will collaborate across disciplines to support study execution, data preparation through database lock, and publication of scientific results.
Key Responsibilities
- Design and develop protocols and statistical analysis plans for clinical trials
- Perform statistical analyses as per analysis plan and collaborate to deliver outputs
- Identify data collection instrument needs and address data issues and assumption violations
- Develop strategy for data presentation and support publication with accurate tables/listings/figures
- Collaborate cross-functionally and explain statistical concepts to non-statisticians
Technical Overview
You will independently develop statistical analysis plans and protocols, specify programming for derived variables and analysis datasets, and run statistical analyses according to the analysis plan. The role also covers evaluation of software suitability for planned analyses and ensuring tables/listings/figures are accurate and internally consistent.
Ideal Candidate
The ideal candidate is a biostatistics/Statistics leader with hands-on clinical trial experience designing protocols and independently creating statistical analysis plans. They can execute statistical analyses, define derived variables and analysis datasets, and ensure publication-quality accuracy for tables, listings, and figures while collaborating cross-functionally.
Must-Have Skills
clinical trials statistical analysisprotocol developmentstatistical analysis plansability to perform statistical computations and simulationseffective communication skills (oral and written)accuracy and internal consistency of reports and publications
Nice-to-Have Skills
pharmaceutical or related industry knowledgeexperience with drug development and life-cycle managementknowledge of regulated environmentglobal medical affairs experiencepatient safety experience
Tools & Platforms
statistical programming
Required Skills
clinical trialsstatistical expertisedesign clinical trialsanalysis clinical trialsreporting clinical trialsprotocolsstatistical analysis plansprogramming implementationsound statistical methodologydata collection instrumentsdata issues identificationstudy assumptionsderived variablesanalysis datasetsdatabase lockstatistical analysesdata presentation strategyinferencepublication of scientific researchtableslistingsfigurescross-functional collaborationstatistical computationssimulationspharmaceutical drug developmentlife-cycle managementregulated environment
Hard Skills
clinical trialsstatistical expertisedesign of clinical trialsanalysis of clinical trialsreporting of clinical trialsprotocol developmentstatistical analysis plansprogramming implementation specificationssound statistical methodologydata collection instrumentsdata issues identificationstudy assumptions violationsderived variablesanalysis datasetsstatistical analysesanalysis plan executiondata presentation strategyinferencestatistical concepts explanationstatistical computationssimulationsdata visualization for publicationtableslistingsfiguresscientific report accuracy and internal consistencysoftware appropriateness evaluationstatistical programming collaborationdatabase lock preparationpharmaceutical drug developmentlife-cycle managementregulated environment knowledgepatient safetyglobal medical affairs
Soft Skills
effective communication skills (oral and written)independent workcollaboration with experts in multiple disciplinescross-functional relationship buildingstakeholder managementexplain statistical concepts to non-statisticiansrelationship building with peers and cross-functional partnersanticipate issuesdrive innovationchallenge the status quohighly motivated
Keywords for Your Resume
Manager Statistics - Clinical TrialsManagerStatisticsclinical trialsstatistical analysis planprotocolsstatistical analysisderived variablesanalysis datasetsdatabase lockstatistical computationssimulationsdata issuesstudy assumptionsdata presentationtableslistingsfigurespublication of scientific researchpharmaceuticaldrug developmentlife-cycle managementregulated environmentpatient safetyglobal medical affairs
Deal Breakers
Must have MS (6+ years) or PhD (2+ years) in Statistics, Biostatistics, or highly related field, Must be able to perform statistical computations and simulations, Must be local to one of: Irvine, CA; San Francisco, CA; Lake County, IL; Florham Park, NJ
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