Summary:
Acts?as?the?lead?statistician?for?multiple?projects?with?any?level?of?complexity.?Acts?as?the?primary?contact?with?the?sponsor?for?all?biostatistics?related?activities?on?assigned?projects.?Serves?as?a?departmental?resource?for?complex?statistical?questions,?study?design?considerations,?and?protocol?development.
Essential?Functions:
1.Maintains?a?good?working?knowledge?of?clinical?drug?development,?ICH?and?other?regulatory?guidelines,?and?biostatistics?in?order?to?effectively?serve?as?a?statistical?department?resource,?mentors?biostatisticians?on?job?skills,?oversees?or?develops?training?plans?or?materials?for?Biostatistics?associates,?conducts?training?sessions,?or?otherwise?trains?new?hires?and?enhances?the?skills?of?existing?personnel.
2.Collaborates?in?the?process?of?protocol?development?by?choosing?an?appropriate?study?design,?including?statistical?methodologies,?calculating?necessary?sample?size?to?achieve?a?pre-specified?power,?and?writing?the?statistical?section?of?the?protocol.?Sample?size?calculations?may?require?some?literature?search?to?ensure?that?the?study?assumptions?are?correct.
3.Writes?and?reviews?Statistical?Analysis?Plans?(SAPs)?based?on?the?protocol,?including?development?of?well-presented?mock-up?displays?for?tables,?listings,?and?figures.?Collaborates?with?sponsor.?Creates?or?reviews?programming?specifications?for?analysis?datasets,?tables,?listings,?and?figures.
4.Directs?the?activities?of?other?Biostatistics?personnel?on?assigned?projects?to?ensure?timely?completion?of?high?quality?work.?Provides?independent?review?of?project?work?produced?by?other?statisticians?in?the?department.
5.Provides?input?to?Standard?Operating?Procedures?(SOPs)?development?and?review.
6.Participates?in?project?teams?as?Biostatistics?representative,?interfacing?as?necessary?with?other?departmental?project?team?representatives.
7.Supports?business?development?activities?by?contributing?to?proposals,?budgets,?and?attending?sponsor?bid?defense?meetings.
8.Participates?in?Data?Safety?Monitoring?Board?and/or?Data?Monitoring?Committee?activities,?including?charter?development?and?serving?as?an?independent?non-voting?statistician.
9.Conducts?and?participates?in?review?and?quality?control?of?project?deliverables,?ensuring?that?output?meets?expectations?and?is?consistent?with?analysis?described?in?SAP.
10.Discusses?time?estimates?for?completion?of?study?related?activities?with?the?Lead?Statistician?or?Biostatistics?management?and?proactively?communicate?to?the?Lead?Statistician?or?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?escalates?to?management.
11.Generates?and/or?reviews?randomization?schedule(s)?to?ensure?there?are?no?errors?present?and?sponsor?and?protocol?requirements?are?met.?Performs?ongoing?monitoring?of?actual?randomization?scheme?applied?by?IVRS/IWRS.
12.Displays?willingness?to?work?with?others?and?assist?with?projects?and?business?unit?initiatives?as?necessary?to?meet?the?needs?of?the?business.
Other?Responsibilities:
Performs?other?work-related?duties?as?assigned.?Minimal?travel?may?be?required?(up?to?25%).
Requirements:
MS?or?PhD?in?Biostatistics?or?related?field.?Extensive?experience?in?clinical?trials?or?equivalent?combination?of?education?and?experience.?Experience?in?SAS?programming.?Experience?with?regulatory?submissions?preferred.?Excellent?knowledge?of?statistical?theory?including?experimental?design,?categorical?data?analysis,?analysis?of?variance?(covariance),?survival?analysis,?and?non-parametric?methods.?Effective?written?and?verbal?communication?skills.?Ability?to?apply?knowledge?of?basic?statistical?design,?analysis,?ICH?guidelines,?and?programming?techniques?utilized?in?clinical?research?and?to?effectively?communicate?statistical?concepts.?Extensive?knowledge?of?the?drug?development?process?and?FDA?and?ICH?guidelines.?Ability?to?read,?write,?speak,?and?understand?English.
