Senior Statistical Programmer Temp
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The Senior Statistical Programmer Temp uses statistical software to generate analysis data sets, tables, listings, and figures as well as any post-hoc analyses. This individual is responsible for developing production statistical output, validating statistical output and managing timelines and reviewing output from vendors.
The Senior Statistical Programmer Temp uses statistical software to generate analysis data sets, tables, listings, and figures as well as any post-hoc analyses. This individual is responsible for developing production statistical output, validating statistical output and managing timelines and reviewing output from vendors. This individual is responsible for assisting with the oversight of all programming aspects ensuring the performance is consistent with Acorda processes and relevant regulatory guidelines. The Senior Statistical Programmer Temp also is involved with the development and validation of in-house standardized programs and processes. This individual provides timely support and project leadership to the study team on all statistical programming matters.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
Education and/or Experience:
- Develops production quality statistical programs for clinical trials and post-hoc requests.
- Reviews and validates statistical programs and output.
- Manages programming timelines and development of deliverables.
- Reviews study-related documents including statistical analysis plans (SAPs), Case Report Forms, QC Plans and Reviewer’s Guides.
- Interacts with Acorda and CRO, project managers, programmers, data managers and statisticians.
- Interacts with team members for study start-up, table production, database lock, unblinding and the generation of final statistical tables, listings and figures.
- Assists Clinical Biometrics with development of tools and techniques for improving process efficiencies such as macros and standard templates.
- Assists Clinical Biometrics with development of Standard Operating Procedures (SOPs) and Work Instructions).
- Bachelor’s degree in Computer Science, Life Science or a related field required.
- Master’s degree in Computer Science, Life Science or a related field preferred.
- Minimum of three to five years of relevant experience.
- Prior experience in the pharmaceutical or biotechnology industries required.
- Extensive knowledge of SAS programming software required.
- Knowledge of additional programming languages preferred.
- CDISC (SDTM and ADaM) experience preferred.
- Must have the ability to work with limited supervision on multiple assignments.
- Must be able to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Must have a general understanding of regulatory guidelines and their application to data submissions.
- Must have strong analytical, critical thinking and mathematical skills.
Certificates, Licenses, Registrations: None requiredOther Skills and Abilities:
- Proficient in SAS programming.
- Proficient in MS Office Suite.
- Knowledge of SQL and R programming desired.
Physical Demands:The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Attention to detail in order to provide high quality outputs.
- Excellent verbal, written and communication skills.
- Ability to work in a team environment with medical personnel, clinical monitors, data managers, clinical programmers, statisticians, and statistical programmers.
- Ability to prioritize, multi-task, and maintain attention to detail.
- Ability to work independently with minimal oversight.
Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.No specific work demands.*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives.