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Principal Statistical Programmer

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Act as technical lead for Oncology Biometrics reporting activities (analysis datasets, pooled datasets, listings and tables) for a global project with minimal guidance and support from group head. Responsibilities also include resource planning, and operational management for a team of 3-10 associates.1.Act as independent lead on the Oncology Biometrics reporting activities for a global project following general principles of project management guidelines including resource planning with minimal guidance and support from group head. 2.Be responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence e.g. RAP including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase. 3.Maintain efficient interfaces with internal and external customers with support of ONC Biometrics management and the Program Programmer/Statistician. 4.Ensure that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials, submission activities and project level specifications e.g. pooled analysis and monitor adherence in execution. 5.Oversee programming style, quality of Oncology Biometrics contributions and ensure compliance with time lines quality within milestones. 6.Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation. 7.Train staff on trial and project level activities and internal processes. 8.Key contributor or sub-team lead on global non-clinical project activities or on process improvement initiatives. 9.Key solution provider on technical subjects or processes, also effectively implementing solutions with a team. Guide others in independently handling issues and problem solving. 10.Operationally manage a team of 3-10 associates including setting yearly objectives and monitoring delivery on projects. 11.Provide input to group head on performance and development planning of team members. 12.Deputize GH on operational tasks and QA of deliverables.Meet established KPIs. Timely and high quality completion of Biometrics deliverables according to established objectives for teams. Contribution to non-clinical project activities. Demonstrated leadershipMinimum requirements University or college degree in life science, computer science, statsitics or equivalent relevant degree. Fluent English (oral and written). 1.6 -8 years of relevant work experience. 2.Expert knowledge and experience with SAS preferred intermediate knowledge of Biostatistical concepts and software (S+, R) for Bios role. 3.Good understanding of global clinical trial practices, procedures, methodologies. 4.Good understanding of regulatory requirements relevant to ONC Biometrics (e.g. GCP, ICH). 5.Good communication and interpersonal skills 6.Ability to develop and coach members Oncology Biometrics team. 7.Demonstrated ability to take responsibility for deliverables. 8.Problem solving abilities, with subsequent issue handling demonstrated.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | ME/ M.Tech./ MS (Engg/ Sciences)

Additional Degree: BE/ B.Tech (Engineering) | B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 6-8


Clinical Research | Data Management/ Statistics | Quality Assurance/ Control
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