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Lead Statistical Programmer


Source:
TIMESJOBS.COM
Location:
Secunderabad, Telangana
Date:
12-11-2016
Job Code:
58263527
Categories:
  • Biotechnology & Science
Applying for this job will take you to an external site
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Job Details

The Lead Statistical Programmer is responsible for all programming aspects (including analysis datasets, pooled datasets, listings, figures, and tables) of individual Phase I-IV clinical trials and project-level activities for a drug project across business unit(s), provide technical expertise to offer consulting, training and mentoring other programmers and supporting operational excellence by working together with the Lead/ Expert/ Principal Statistician (Statistician).1. Responsible for the integrity of the programming/computing solutions for a global clinical program, regional and CPO clinical activities. 2. Act as the scientific lead for programming expertise liaising with the Statistician and statistical scientific counterparts within the team for a clinical project. 3. Lead the full execution of final production output generation of quality, timely programming deliverables for CSRs, regulatory submissions/interactions, publications, and market promotions within the drug development program globally. 4. In conjunction with the Statistician, develop/support the project-level programming standards and ensure compliance with project-level/disease-area/company standards. As required, provide support to development of disease-area programming standards, following internal guidelines. 5. Ensure that documents and specifications are consistent and comply with company standards by providing input into eCRFs and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities within the responsible drug project. 6. Lead/program (according to established specifications) analysis datasets, pooled datasets, listings, tables, figures, and listings for Phase I-IV clinical trials and for regulatory submissions (e.g., SCS, SCE and RMP/safety update, value dossier) and for other project support (e.g. publications and market promotion) according to established milestones, as needed. 7. In consultation with the Statistician, responsible for development/update of project-level programming specifications of analysis datasets and pooled datasets (e.g. in RAP, MAP and CSPD) for the clinical drug project, as needed. 8. Ensure QC compliance and responsible for project records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality programming deliverables for the drug project. 9. Assume the role of subject matter expert / trial domain expert to ensure seamless outsourcing, according to the agreed contract and internal business guidance. 10. Mentor/coach programmers in functional expertise and process for project support; as required, support training/development of new programming applications. 11. As required, participate in process improvement initiatives or other non-clinical project activities. 12. Develops advanced MACROs for general use of programmers. Problem solving and solution oriented; programming representation in the Clinical Project Team and PLSS project team. Internal and external satisfaction with final programming outputs used for the Clinical Project as assessed by customers, Group Leader. Effectiveness of communication and team behaviors as assessed by the other members of the Clinical Project Team and PLSS project team. Quality and timeliness of programming contributions as assessed by the Clinical Project Team, PLSS project team/ Group Leader. Ability and effectiveness in training and mentoring programmers in the PLSS project teams.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | MD/ MS (Medicine)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 8-13

Requirements

Bio-Statistician | Chemical Research | Data Management/ Statistics | Documentation/ Medical Writing
Applying for this job will take you to an external site

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