Essential?Functions:
1.???????Line?management?of?staff?including:?performance?management,?progressive?discipline,?and?training?need?identification.?Recommends?courses?of?action?on?salary?administration,?transfers,?new?hires,?terminations,?and?professional?development.?Regularly?communicates?with?staff?on?working?practices,?policies,?and?work?instructions.
2.????Meets?with?Biostatistics?managers,?routinely?to?evaluate?and?develop?solutions?for?project?resourcing,?quality,?timelines,?budget,?standard?processes,?and?training?needs.?Keeps?senior?management?informed?of?decisions?and?issues?which?impact?the?department.
3.????Ensures?that?the?local?and?regional?Biostatistics?department?meets?timelines,?provides?high?quality?deliverables,?complies?with?contractual?project?requirements,?and?identifies?the?need?for?contract?modifications?due?to?out?of?scope?activities.
4.???????Assigns?Biostatisticians?to?projects?in?a?manner?which?aims?to?keep?associates?at?their?utilization?goal?and?which?matches?associates?to?projects?appropriate?to?their?skills,?training,?and?experience,?while?also?providing?opportunities?to?work?with?varied?projects,?sponsors,?and?teams.
5.???????Prioritizes?activities?across?biostatistics?projects?and?facilitates?mutually?beneficial?resolutions?to?project?conflicts?between?groups?or?individuals?which?promotes?teamwork?and?quickly?restores?department?effectivenes.
6.????Responsible?for?staff?development?to?facilitate?succession?planning?and?maintaining?a?biostatistics?staff?with?diverse?skills,?abilities,?and?competencies?meeting?the?business?needs?of?Biostatistics?department.
7.????Sets?challenging,?achievable?goals?for?associates?which?contribute?to?department?objectives?and?supports?efforts?to?achieve?those?goals.?Provides?motivating,?timely?performance?feedback?to?associates?on?a?routine?basis?as?well?as?for?formal?performance?appraisals.
8.????Supports?business?development?activities?by?contributing?to?proposals,?request?for?information,?budgets,?and?attending?sponsor?bid?defense?meetings.
9.????Conducts?senior?review?of?project?deliverables,?ensuring?that?output?meets?expectations?and?is?consistent?with?analysis?described?in?study?documents.
Requirements:
MS?or?PhD?in?Biostatistics?or?related?field.?Extensive?experience?in?clinical?trials?or?equivalent?combination?of?education?and?experience.?Experience?with?regulatory?submissions?preferred.?Some?management?experience?preferred.?Extensive?knowledge?of?the?drug?development?process?and?FDA?and?ICH?guidelines?and?demonstrated?leadership?ability.?Effective?written?and?verbal?communication?skills.?Ability?to?apply?knowledge?of?statistical?design,?analysis,?and?programming?techniques?used?in?clinical?trials.?Ability?to?read,?write,?speak,?and?understand?English.
