Statistical Programmer Position
Objective of Position
The Statistical Programmer is responsible for all aspects of the statistical programming process from the extraction of clinical trial raw data through the finalization of project deliverables. This includes the generation of study-specific and ad-hoc clinical data listings, summary tables and figures. The statistical programmer may have project level oversight of junior statistical programmers.
Essential Duties/ Responsibilities
- Performs data analysis using SAS programming language (primarily) for the summary and interpretation of clinical trial data.
- Creates CDISC SDTM and ADaM files, SAS transport files and Define.xml used for Electronic Submission from the data received in non-standard form from various sources.
- Performs Data analysis, statistical analysis, generates safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Reviews Data Management Plan, Data validation plan and edit check specifications.
- Interacts with Statisticians and clinical teams, performs ad hoc analysis and generates outputs according to the requirements.
- Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form (CRF) design and data collection.
- Recognizes inconsistencies and initiates resolution of data problems.
- Acts as a liaison between statistical programming, subcommittees and project teams as needed.
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
- Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
- Acts independently to determine methods and procedures on new assignments.
- May provide guidance to other lower level personnel.
- Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP).
- Develops SAS coding and table templates for preparing, processing and analyzing clinical data.
- Creates/acquires tools to improve programming efficiency or quality.
- Medical Affairs knowledge required.
- PK/PD knowledge preferred.
- Excellent written and verbal communication skills.
- Strong project management skills.
- MS or BS in Statistics, Mathematics, Computer Science, Natural Sciences, Informatics, or related field or equivalent (of theoretical/technical depth).
- Experience in statistical programming or statistics in the pharmaceutical or biotechnology industry.
To apply for this position, please send your resume to firstname.lastname@example.org
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. This document may be changed at management’s discretion.
Acerta Pharma is an equal opportunity employer. Acerta Pharma will consider all qualified applicants for employment, and all qualified contractors for Acerta Pharma contract positions, without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Acerta Pharma only employs individuals, and engages contractors, with the right to work in the country/ies where the role is based.
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