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11 Novotech Jobs
Senior Statistical Programmer
3-6 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Senior Statistical Programmer
Novotech
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Review a clinical study protocol with regards to statistical programming responsibilities.
- Assess study related workload and project timelines and discuss programming time estimates and risk mitigation plans with Statistical Programming Team Lead for inclusion in resource forecasts.
- Review and provide input to a Statistical Analysis Plan (SAP) with respect to presentation of data and results (tables, listings, figures).
- Develop and maintain SDTM and ADaM or analysis datasets specifications for assigned projects.
- Undertake peer review of SDTM and ADaM or analysis datasets specifications from junior staff as required.
- Program SDTMs, ADaMs or analysis datasets, tables, figures, and listings (TFLs) according to approved specifications.
- Adhere to company statistical programming standards and conventions, and data standards.
- Ensure that SAS programs generated for data storage, transformation, presentation and statistical analysis are properly documented and traceable.
- Maintain study documentation, programs and files within project files and maintain timesheets.
- Represent Novotech at client meetings as required.
- Undertake gap analysis across the clinical study databases that need to be part of the data package with respect to the standardization and transformation efforts required.
- Develop project plan to generate the package and estimate costs in consultation with Line Manager and Biostatistics.
- Develop programs to generate SDTM datasets, SDTM annotated CRF, AdaM datasets, Define.xml datasets, Reviewers Guides, and related regulatory documents required for submission.
- Participate in Statistical Programming section meetings, Biostatistics meetings and Biometrics department meetings.
- Mentor junior staff in technical matters and assist in induction of new staff.
- Contribute to developing company programming conventions and SAS macros.
- Contribute to automating statistical programming tasks and progress tracking.
- Advise Clinical Data Management and Clinical Data Programming with respect to CRF libraries and data dictionaries based on CDASH and SDTM.
- Ensure compliance with applicable regulatory agency guidelines and Novotech s corporate policies and SOPs, and SOPs for study design, protocol development and all other statistical programming output.
- Participate in industry forums (conferences, professional association committee work etc.) as required.
Employment Type: Full Time, Permanent
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