Regeneron Pharmaceuticals Contract Senior Statistical Programmer PMx in Tarrytown, New York
A senior statistical programmer (contractor) provides timely support to the study team on all programming matters according to the project strategies in Pharmacometrics Department in DSP. As an integral part of a study, the incumbent provides programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan, clinical pharmacolgy reports requirement and programming specifications using internal standards and guidelines. Supporting the evaluation and development of study requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment.
•Responsible for transfer data from the LIMS (BA) and clinical data, prepare merged data sets for pharmacokinetic analysis.
•Create CDISC compliance analysis datasets (SDTM, ADaM) according to the SAP and programming specification
•Generate tables/figures to include but not limited to: accounting for the disposition of patients and samples, descriptive statistics of pharmacokinetic variables, and results, concentration over time, pharmacokinetic parameters over dose, concentration effect relationship, and PK/PD analyses.
•Support the electronic data submission for BLA
•Basic understanding of biostatistics, experienced in data handling, process and analysis
•Able to take directives and work independently
•Excellent interpersonal skills
•Manage and prioritize multiple programs with competing and aggressive time lines with supervisio
Essential job functions:
Programming and QC of analysis datasets, TFL's or standard tools following Regeneron standard data models or user requirements. Representation of PM programming functions and coordination of activities with cross line functions and communicate shifting timelines and milestones.
• Integration of data across studies in support of CSS/CSE/CSP. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies.
• Support creation and validation of e-submission requirements (i.e. annotated CRF, data export files, define documents).
• Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports,. If applicable, develop and provide department training for applications and standard tools developed by the department functions group.
• Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations.
• Participate in department working groups; provide input in development of tools and improvement of processes.
This position requires a minimum of a degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with a minimum of 3+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. SAS Certification desirable.
Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc.
o Strong SAS programming skills in a clinical data environment.
o Strong understanding of relational database structure.
o Understanding of reporting systems utilizing multiple data delivery applications.
o Strong Experience/knowledge with implementing standardization methodology, creation of current CDISC data standards.
o Demonstrated teamwork and interpersonal skills. Ability to problem solve. Strong verbal and written communication skills in a global environment.
o Knowledge of pharmaceutical clinical development (i.e. understanding safety deliverables, efficacy analysis, in addition pharmacokinetic/pharmacodynamic and exposure-response is desired) and ability to provide programming support needs for BLA and other regulatory submissions.
o Ability to organize and manage multiple assignments with challenging timelines .
o Problem solving and innovative skills.
o Familiarity with the development and execution of user requirements, validation plans, operational and performance protocols.
SAS (Base, Stat, Macro, graph), R knowledges is preferred.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.