||Aug 09, 2019
||3 yrs- 5 yrs
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
A senior statistical programmer 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 project leadership and 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. The incumbent assists in providing guidance in implementing and executing the programming and project standards. 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
- Growth opportunity for this individual is in the area of Pharmacokinetics; both non-compartmental and compartmental, as in the use of NONMEM, pharmacokinetic simulation and population pharmacokinetics.
- 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 supervision.
- Support the Preclinical Pharmacokinetics department as needed.
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 esubmission 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.
- MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 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. in accordance with existing policies and standards for application to specific problems or tasks.
- Strong SAS programming skills in a clinical data environment.
- Strong understanding of relational database structure.
- Understanding of reporting systems utilizing multiple data delivery applications.
- Strong Experience/knowledge with implementing standardization methodology, creation of current CDISC data standards.
- Demonstrated teamwork and interpersonal skills. Ability to problem solve. Strong verbal and written communication skills in a global environment.
- 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.
- Ability to organize and manage multiple assignments with challenging timelines for a limited number of personnel.
- Problem solving and innovative skills that demonstrate initiative and motivation.
- Familiarity with the development and execution of user requirements, validation plans, operational and performance protocols.
- SAS (Base, Stat, Macro, graph), basic R knowledge is plus.
- May report to a Manager or above
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.