Statistical Programmer
Statistical Programmer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Provide statistical programming support to generate SDTM and ADaM datasets tables listings and figures for individual studies and ISS/Client to FDA EMA and other worldwide regulatory agencies.
- Participate in the review of statistical analysis plans and TLF specifications.
- Review or annotate CRFs for SDTM mapping review/author SDTM/ADaM dataset specifications.
- Review and comment on CRFs vendor data transfer specifications (DTS) edit checks and other study data related documents.
- Support in the preparation of study reports regulatory submissions and annual safety update reports.
- Perform additional analysis and validation for data checking publication presentation poster and ad hoc analysis.
- Work with CRO statistical programmers and perform statistical programming vendor oversight.
- Contribute to Biometrics SOPs and work instructions related to EDC studies FDA requests and statistical programming processes.
- Contribute to department process improvement initiatives.
- Support department infrastructure builds up by developing validating and testing the macros utilities and tools.
- Keep abreast of literature and advancements in SAS.
Requirements:
- Bachelors or masters degree in biostatistics computer science or related fields masters degree preferred.
- At least 8 years of relevant experience including as a Lead Statistical Programmer in the biotech or pharmaceutical industry.
- The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
- Proficient of SAS programming in a regulated clinical research environment.
- Experience of programming and validation of SDTM and ADaM data sets tables figures and listings.
Employment Type
Full-time
