Job Description
Long-term remote FSP
- West-coast based (pacific or mountain time)
- Min. 12 (ideally 15) years of statistical programming experience.
- Prior experience leading/managing projects/people is critical
- Must have extensive experience with Kaplan-Meierplots
- Must have great communication skills, ability to work independently
Responsibilities will include, but are not limited to, the following:
- Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
- Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
- Perform programming validation to ensure the quality of analysis datasets and programming outputs.
- Ensure consistency and adherence to standards within the project.
- Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
- Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission.
- Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
- Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
- Serve as lead programmer in support of NDAs, sNDAs.
- Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables.
- Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
- Contribute to the creation, maintenance, and validation of standards for outputs and macros.
- Provide training on SOPs, WPs and standard programs.
- Contribute to the creation of naming conventions and development of the programming environment.
- Oversee the services provided by CROs.
Skills/Knowledge Required:
- Bachelor’s Degree in life science, statistics, mathematics, computer science, or related field is required; Master’s Degree is preferred.
- Min 12 years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions.
- Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
- Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
- Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
- Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
- Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
- In-depth understanding of regulatory, industry, and technology standards and requirements.
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
- Demonstrated ability to work in a team environment with clinical team members.
- Good planning and project management skills.
- Good interpersonal, communication, writing and organizational skills.
Job Tags
For contractors, Remote job, Flexible hours,