Remote Sr Statistical Programmer

Requirements
Minimum education: Master
Years of work experience: 8 year(s)

Responsibilities

A biotechnology leader on the east coast needs multiple Senior Statistical Programming consultants to support their team on a long-term basis. This is an exciting opportunity to be part of a strong FSP team for our client's multiple programs and growing pipeline.

The team is preparing for submission, so these consultants will need to be experienced and able to come in and hit the ground running. They will be strong hands-on contributors to the team, providing support through the production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components and ad hoc analyses. They will also need to have ISS/ISE safety data expertise.

These opportunities are fully remote, and east coast working hours must be accommodated.

Experience required:

• 8+ years of Statistical Programming experience within the life science industry, preferably on the Sponsor side, and relevant BS degree
• Must have experience performing data manipulation, analysis, and reporting of clinical trial data specifically for both safety and efficacy (ISS/ISE)
• Experience producing TLFs, outputs, reports, and QCing outputs effectively
• Expertise with SAS statistical software (and other statistical software such as JMP-Clinical, Pinnacle 21, and R)
• Strong knowledge of CDISC (SDTM & ADaM)
• Experience supporting regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines
• Experience and understanding of drug development process and clinical trials

Responsibilities Include:

• Hands-on SAS Programming for the creation and QC of clinical Tables, Listings, and Graphs
• Perform validation and QC of the programs, datasets, and statistical reports per study requirements.
• Authors SDTM and ADaM dataset specifications including the identification of potential data issues or areas of critical data examination
• Works with Biostatistics on defining and documenting programming endpoint algorithms
• Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components
• Partners with Biostatistics to deliver high-quality, submission-ready statistical outputs
• Other related programming activities as required

Experience required:

• 8+ years of Statistical Programming experience within the life science industry, preferably on the Sponsor side, and relevant BS degree
• Must have experience performing data manipulation, analysis, and reporting of clinical trial data specifically for both safety and efficacy (ISS/ISE)
• Experience producing TLFs, outputs, reports, and QCing outputs effectively
• Expertise with SAS statistical software (and other statistical software such as JMP-Clinical, Pinnacle 21, and R)
• Strong knowledge of CDISC (SDTM & ADaM)
• Experience supporting regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines
• Experience and understanding of drug development process and clinical trials

Skills : CDISC