Manager – Biostatistical Programming
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The Manager – Biostatistical Programming represents Acorda statistical programming on project/study teams, collaborates with trial team members, and may supervise programming staff. This individual is responsible for leading the development and maintenance of internal analysis programs and clinical data standards tasks, as well as the oversight of CRO statistical programming and related deliverables.
The Manager – Biostatistical Programming represents Acorda statistical programming on project/study teams, collaborates with trial team members, and may supervise programming staff. This individual is responsible for leading the development and maintenance of internal analysis programs and clinical data standards tasks, as well as the oversight of CRO statistical programming and related deliverables. The Manager – Biostatistical Programming is responsible for ensuring that project work adheres to relevant regulatory guidelines (e.g. FDA and ICH) and relevant Standard Operating Procedures (SOPs). This individual supervises the use of statistical software (e.g. SAS) to generate analysis data sets, tables, listings, figures, and post-hoc analyses. The Manager – Biostatistical Programming also may directly generate production or validation statistical programs and related deliverables.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Manages the development of standard programs and software to generate standard datasets, analysis files, tables, listings, and figures.
- Contributes to the development of specification documents for standard datasets, analysis files, tables, listings, and figures.
- Troubleshoots for staff regarding specific programming concerns.
- Reviews statistical programming deliverables including standard datasets, analysis files, tables, listings, figures, and validation programs.
- Provides oversight to internal and external programmers with regards to data standards (e.g. CDISC) and programming.
- Contributes to the development of and training on SOPs related to programming.
- Interacts with medical leads, clinical project managers, programmers, data managers, and statisticians from both Acorda and CROs.
- Develops tools and technique, such as templates, processes, and macros, for improving process efficiencies.
- Contributes to the overall development and management of the statistical programming team, and may complete performance reviews and provide feedback for development of staff.
Education and/or Experience:
- Bachelor’s degree in Computer Science, Life Science or related field required.
- Master’s degree in Computer Science, Life Science or related field preferred.
- Minimum of four to six years’ experience in statistical programming required.
- Prior experience in the pharmaceutical or biotechnology industries required.
- Prior experience with CDISC standards required.
- Prior experience with electronic data capture systems preferred.
- This individual may manage programmers in the Clinical Biometrics department.
- Ability to work on multiple assignments with minimal supervision.
- Must be able to exercise judgment within broadly defined practices and policies in selecting methods and techniques for the development of computer programs.
- Must have a good understanding of regulatory guidelines and their application to data standards and other aspects of statistical programming
- Strong analytical, critical thinking, and mathematic skills.
- Extensive knowledge of SAS programming required
- Must be proficient in MS Office Suite.
- Knowledge of SQL and R programming desired.
Certificated, Licenses, Registrations: none required
Other Skills and Abilities
- Must have excellent verbal and written communication skills.
- Ability to work under pressure and adhere to deadlines.
- Ability to manage and lead a team of programmers or vendors.
- Ability to work in a team environment with medical personnel, clinical monitors, data managers, clinical programmers, statisticians, and statistical programmers.
- Ability to effectively present information to management.
- Must stay abreast of latest developments in the field of programming and data standards.
- Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
- Ability to prioritize and multi-task successfully in a fast-paced environment.
- Strong analytical and problem solving skills.
- Must demonstrate a keen attention to detail and adherence to timelines.
- Ability to work both independently and in a collaborative team setting.
- Excellent time management skills and an ability to work on multiple projects at any given time.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position requires minimal travel; average travel for this position is 5% with some variation based upon the demands of the business imperatives.
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.