Remote, 12-month contract with potential to renew
Senior Statistical Programming Consultant
Responsibilities:
- Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/ISE 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
- Keep abreast of literature and advancements in SAS.
Qualifications:
- Bachelor’s or Master’s degree in biostatistics, computer science, or related fields, Master’s degree preferred;
- At least 6 years of relevant experience 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.
