Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Clinical Programmer

Expired Job

NJ Employer Berkeley Heights , NJ 07922

Posted 2 months ago

DescriptionThis is for Statistical Programming role Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. Oncology experience preferred.

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. Perform programming validation to ensure the quality of analysis datasets and programming outputs.

Ensure consistency and adherence to standards within the project. Provide input to the design of the clinical trial database for proper data capture and to ensure data quality. Create Data Definition Tables (DDT) and converting TFLs to the required format for eSubmission.

Provide programming support for the preparation of integrated reports, submissions and post-submission activities. Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets. Serve as the lead programmer in support of NDAs, sNDAs.

Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables. Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.

Contribute to the creation, maintenance, and validation of standards for outputs and macros. Provide training on SOPs, WPs and standard programs. Contribute to the creation of naming conventions and development of the programming environment.

Oversee the services provided by CROs. Skills/Knowledge Required: Bachelors Degree in life science, statistics, mathematics, computer science, or related field is required; Masters Degree is preferred. 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions or equivalent experience.

Demonstrated proficiency in using SAS to produce derived analysis datasets and 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 planning and project management skills.

Good interpersonal, communication, writing and organizational skills.#LI-NV1EEO EmployerApex 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 or .VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any o

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Sdtm Clinical Programming

Celgene Corporation

Posted 1 week ago

VIEW JOBS 11/8/2018 12:00:00 AM 2019-02-06T00:00 Associate Director SDTM, Clinical Programming Req #: 1803933 Location: Berkeley Heights, NJUS Job Category: Information Technology Work Location: 300 Connell Dr BERKELEY-300 07922 Organization: Celgene Corporation Schedule: 40 Shift: Employee Status: Full time Job Type: Regular Job Level: Travel: Other Locations:US- NJ- Berkeley Heights- 300 Description Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Responsibilities will include, but are not limited to: Programming Leadership: * Responsible for supervising Programmers by planning/assigning workload * Responsible for performance evaluations and development of direct reports including identifying opportunities for cross functional collaboration * Act as a coach/mentor and model behaviors to set examples for programmers, responsible for the overall performance of each of their team members * Manages team conflicts to resolution and improved team collaboration * Lead/participate in implementation of processes and technologies consistent with strategy * Expert at leveraging limited resources for maximum impact on projects and initiatives * Monitor and forecast programming resource needs and ensure that projects are sufficiently resourced * Monitor projects to ensure consistency and adherence to SOPs and best practices * Represent as technical expert who decides best course of action and leverage networks to achieve influence with others * Develop Therapeutic Area SDTM programming strategy and collaborate with other functions in regards to programming deliverables e.g. SDTM specifications, submission activities, high level project algorithms * Participate in Project/Study Team meetings as needed to provide SDTM programming expertise and creative solutions to problems * Experience with standard governance organizations * Conduct cross functional meetings to gain trust and respect of team members, makes decisions on business issues, and freely challenges and expresses perspectives * Work with CROs at the alliance level to ensure consistency across therapeutic areas and ensure alignment with department/company strategy * Work closely with CROs to build/maintain positive relationships, negotiate timelines/budgets, successfully manage conflicts and thoroughly understand the CRO processes Other Key Activities: * Contributes to development and execution of department strategy * Develop job descriptions and career paths for programmers * Ensure consistency and adherence to standards and governance within their therapeutic area and the department * Lead/contribute to the creation, maintenance and validation of standards for programming tools, outputs and macros as well as naming conventions; and offer training on the same * Lead/participate in department and/or cross-functional process improvement initiatives, special projects and regularly disseminate information to teams and stakeholders * Evaluate and assign resources needed to support initiatives and special projects * Independently manage resources and timelines for special projects, and collaborate with other departments and external partners during the execution * Author, review, approve and train on department procedures including SOPs, Working Practices and Guidance Documents * Represent programming during internal audits as well as Health Authority audits * Provide training and continuous feedback to new programmers to ensure their proficiency with Celgene standards and processes * Proactively anticipate problems, identify root causes and implement creative solutions * Build inter-departmental relationships and resolve issues as needed * Participate in industry wide technical discussions Skills/Knowledge Required: * Strong knowledge of CDSIC Standards, SDTM, data capture, database design, programming requirements for drug development and regulatory requirements is required, as well as prior experience in managing the programming function * BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 9 years of experience as a Clinical Programmer, Statistical Programmer, or SAS Programmer * Minimum 5 years of management experience * Demonstrates direct and indirect management skills, strong project management skills; good communication skills; ability to work in a cross-functional team environment * Expert in CDSIC standards including CDASH or SDTM/ADaM * Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats * Knowledge of clinical study design. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, and data validation * Demonstrates expertise in providing outputs to meet downstream requirements (e.g., ADaM, Data Definition Table, e-submission) * Demonstrates expertise in the handling and processing of upstream data (e.g., multiple data sources, data workflow, eDC, SDTM) * Proficient in programming languages and demonstrates proficiency in using SAS a plus * Advanced knowledge of clinical database design and programming practices * Knowledge of data management systems (Rave, InForm, or OC RDC) and/or good understanding of SAS datasets and procedures. Familiar with reporting tools (e.g. JReview, SpotFire) * In-depth knowledge of FDA/ICH guidelines, industry/technology standard practices and good programming practices * Good understanding of clinical data and pharmaceutical development * Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs Medical or mathematics/computer science background a plus BA/BS in a relevant scientific discipline; minimum 9 years of experience as a programmer in a pharmaceutical/CRO setting with a leadership role. Regulatory submissions experience with expertise in CDSIC/SDTM Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Celgene Corporation Berkeley Heights NJ

Clinical Programmer

Expired Job

NJ Employer