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Associate Director, Stat Programming

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

Technical responsibilitiesi) Serve as a Stat Programming consultant for other members of the department and staff members from other Biostatistics departments within the company.ii) Maintain knowledge and awareness of developments in statistical programming.iii) May participate as high level lead Stat Programmer on major project(s).iv) Provide advanced technical expertise for internal and external clients.v) Independently bring project solutions to SP teams and the Statistical Programming Provide expert review of process and methodology development work with regard to SP standards and validation procedures.Manage staff in accordance with organizations policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resource matters.Ensure the high quality and timeliness of deliverables from the Stat Programming department and ensure the high quality of the QC expert review process.Participate in project meetings; keep up-to-date on project issues; keep Director informed of project issues.Coordinate and participate in process improvements and interoffice/interdepartmental task forces; oversee collection and reporting of Stat Programming metrics, implementation of revised work practices, new guidelines, and new software tools as they become available.Effectively allocate at the site level so as to achieve target utilization rates and project realization rates.Manage project budget and resource requirements understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and provide revenue and resource forecasts for groups of studies, integrated summaries or eSubmissions.Participate in sales meetings as required; oversee proposal preparation; ensure that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions. All responsibilities are essential job functions unless noted as nonessential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIESExpert knowledge of SAS and technical database skillsKnowledge of statistics and/or the clinical drug development process (Phase I V)In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesExcellent written and oral communication skills with good interpersonal skillsExcellent problem solving skillsExcellent presentation skillsSound judgment/decision makingAbility to lead and motivate a teamAbility to effectively delegate workAbility to effectively motivate other staff membersAbility to establish and maintain effective working relationships with coworkers, managers and clientsAbility to negotiate project deliverable timelines with clientStrong ability to communicate problems/issues along with experience of developing action plans or alternatives for resolutionQualifications MINIMUM REQUIRED EDUCATION AND EXPERIENCEMaster's degree in computer science or related field and 7 years relevant experience including 2 years experience managing staff; Bachelor's degree or educational equivalent in computer science or related field and 8 years relevant experience including 2 years experience managing staff; or equivalent combination of education, training and experiencePHYSICAL REQUIREMENTSExtensive use of telephone and face-to-face communication requiring accurate perception of speechExtensive use of keyboard requiring repetitive motion of fingersRegular sitting for extended periods of time
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 8-13


Clinical Research | Data Management/ Statistics | Research Scientist
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