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- Berkeley Heights New Jersey, NJ
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Statistical Programmer - SAS, Oncology
Apex Systems • Berkeley Heights New Jersey, NJ
Posted 1 month ago
- Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
- Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
- Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
- Ensure consistency and adherence to standards within their therapeutic area.
- Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
- Oversee the services provided by CROs.
- Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros.
- Provide training on departmental SOPs/WPs and standard programs.
- Contribute to the creation of naming conventions and standards for the programming environment.
- Participate in industry wide technical discussions.
- Bachelor’s degree in life science, statistics, mathematics, computer science, or related field is required; Master’s degree is preferred.
- 8+ years in Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor’s degree; or 5+ years experience with a MS/MA degree.
- Experience in Oncology is highly preferred; Hematology Cancer (i.e. CLL) and Medical Affair Projects are preferred.
- Experience with applying the censoring rules on Oncology studies is preferable, as is efficacy derivations.
- Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs.
- Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
- Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
- Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
- Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
- In-depth understanding of regulatory, industry, and technology standards and requirements.
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
- Demonstrated ability to work in a team environment with clinical team members.
- Good interpersonal, communication, writing and organizational skills.
***For immediate consideration, please email your updated resume to firstname.lastname@example.org with 'Statistical Programmer 952306' in the subject line.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178