Job?Description:
?Provides?support?across?all?assigned?statistical?tasks?during?the?lifecycle?of?the?project,?from?protocol?to?CSR.?Prepares?Statistical?Analysis?Plans?(SAPs),?including?development?of?well-presented?mock-up?displays?for?tables,?listings,?and?figures.?Collaborate?with?the?sponsor,?if?required.?May?be?responsible?for?the?statistical?aspects?of?the?protocol,?generation?of?randomization?schedule,?publications?and?input?to?the?clinical?study?report.?Creates?or?reviews?programming?specifications?for?analysis?datasets,?tables,?listings,?and?figures.?Reviews?SAS?annotated?case?report?forms?(CRFs),?database?design,?and?other?study?documentation?to?ensure?protocol?criteria?are?met?and?all?data?is?captured?as?required?to?support?a?high?quality?database?and?the?planned?analysis.?Conducts?and?participates?in?verification?and?quality?control?of?project?deliverables,?ensuring?that?output?meets?expectations?and?is?consistent?with?analysis?described?in?SAP?and?specifications.?Serves?as?biostatistics?representative?on?project?teams,?interfacing?as?necessary?with?other?departmental?project?team?representatives.?This?would?include?preparing?in?advance?for?internal?meetings,?contributing?ideas,?and?demonstrating?respect?for?opinions?of?others.?Manages?scheduling?and?time?constraints?across?multiple?projects,?sets?goals?based?on?priorities?from?management,?adapts?to?timeline?or?priority?changes?by?reorganizing?daily?workload,?and?proactively?communicates?to?biostatistics?management?any?difficulties?with?meeting?these?timelines.?Monitors?progress?on?study?activities?against?agreed?upon?milestones?and?ensures?the?study?timelines?for?project?deliverables?are?met.?Identifies?out?of?scope?tasks?and?escalate?to?management.?Provides?statistical?programming?support?as?needed.?May?participate?in?Data?Safety?Monitoring?Board?and/or?Data?Monitoring?Committee?activities,?including?charter?development?and?serving?as?an?independent?non-voting?biostatistician.?May?lead?projects?involving?integrated?analyses,?attend?regulatory?agency?meetings?or?respond?to?questions,?as?needed,?to?support?the?statistical?analysis?results?of?clinical?trials?on?behalf?of?the?sponsor.?Supports?business?development?activities?by?contributing?to?proposals,?budgets,?and?attending?sponsor?bid?defense?meetings.?Coaches?and?mentors?other?Biostatistics?staff.
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QUALIFICATION?REQUIREMENTS?
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???Graduate?degree?in?biostatistics?or?related?discipline.??Moderate?experience?in?clinical?trials?or?an?equivalent?combination?of?education?and?experience.??Proficiency?in?programming.??Ability?to?apply?knowledge?of?statistical?design,?analysis,?relevant?regulatory?guidelines,?and?programming?techniques?utilized?in?clinical?research?and?to?effectively?communicate?statistical?concepts.??Experience?across?all?statistical?tasks?required?to?support?clinical?trials?during?the?lifecycle?of?the?project,?from?protocol?to?CSR.??Excellent?written?and?verbal?communication?skills.??Ability?to?read,?write,?speak,?and?understand?English.