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Become A Clinical Statistical Programmer

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Working As A Clinical Statistical Programmer

  • Interacting With Computers
  • Making Decisions and Solving Problems
  • Getting Information
  • Identifying Objects, Actions, and Events
  • Communicating with Supervisors, Peers, or Subordinates
  • Mostly Sitting

  • Repetitive

  • $88,559

    Average Salary

What Does A Clinical Statistical Programmer Do At Regeneron Pharmaceuticals

* Support and/or lead programmer for programming and QC of analysis datasets, TFL's or standard tools following Regeneron standard data models or user requirements.
* Assist in the coordination of activities and communicate shifting timelines and milestones.
* Integration of data across studies in support of CSS/CSE.
* 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 reprots,.
* 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.
* Adheres all direct reports about the procedures surrounding retention of data, records, and information for employees in their group

What Does A Clinical Statistical Programmer Do At System One Services

* 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.
* 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.
* Location:Berkeley Heights, NJ
* Duration:01/29/2018 to 07/30/2018
* Apply

What Does A Clinical Statistical Programmer Do At Boehringer Ingelheim

* As a mentor to other programmers, ensures staff members adhere to the SOPs, guidelines and local working instructions.
* Assist in the updating of these documents as requested by the manager.
* Assists in the development of department procedures and processes to gain efficiencies
* Communicates with the Contract or Academic programmer when part of the trial programming or double programming is outsourced.
* As a principal project programmer, lead a team of programmers located in different OPUs and distribute work packages accordingly.
* Monitor implementation of the work packages and train assigned programmers in the programming concept.
* Implement documentation and tracking tools.
* As a PPROG or PPROG
* TMCP, provide support for the electronic submission to regulatory agencies worldwide.
* This may include the preparation of TMCP analyses or safety and efficacy analyses datasets, data files, application programs, and electronic documentation and user manuals.
* Perform validation activities to ensure the quality of the submission.
* Keep abreast of international data standards (e.g.
* CDISC) and supply programming support to the project team to accomplish this requirement from the regulatory authorities.
* Review and provide feedback to the project statistician regarding the scientific portion of the statistical analyses plan and the shell mock-ups for completeness, correctness and adherence to cited department guidelines and SOPs.
* Author or co-author the Analysis Data Set (ADS) specification with the statistician.
* Challenge the Technical TSAP and PSAP to ensure the most standardized and efficient processes can be used for its implementation.
* Ensure programming issues are resolved and specifications are kept updated in the SAP.
* Communicate and collaborate with the CRO programmer when any part of the programming is outsourced.
* Transform specifications in the Project Statistical Analyses Plans (PSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report.
* This includes: standard displays that require complex data building programming prior to the call of a standard macro; moderate to complex safety displays that cannot be produced by the use of a standard macro; efficacy displays that require applied statistics knowledge in order to produce well documented tested efficacy programs; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods; and implement tables as specified in the MQR plan.
* Reviews the TLFs across the displays for consistency prior to review by the statistician.
* Maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid the department's overall efficiency.
* The PPROG develops a project programming strategy with the PSTAT and PDM, involving the trial teams as well.
* Define critical steps and decisions to be made to enable timely reporting in phase III on trial and project level.
* Implement project programs as much as possible and enable usage across trials.
* Delegate parts of programming development to other team members, providing necessary oversight.
* Communicate and collaborate with the CRO programmer when part of the trial programming or double programming is outsourced, providing any necessary oversight.
* Receives broad operating instructions in performing a majority of duties from manager and keeps manager abreast of programming status and issues.
* Represents the Statistical Programming function on multi-disciplinary, international working groups, with the ability to lead international working groups, FDA or industry developed committees.
* Helps create or provide training materials in supported area.
* Proactively propose effective and efficient implementation methods of TMCP related statistical aspects.
* Translation of statistical analyses of Clinical Pharmacology (CP) and Biomarker (BM) data on trial and project level into programming code using R and SAS.
* Responsible for statistical implementation TMCP parts of submission package (e.g. integrated & meta-analysis of PGx, BM, PK/PD) & exploratory data analysis of TMCP trials.
* Development of TMCP specific programming tool box, e.g. clustering, re-sampling, simulations

What Does A Clinical Statistical Programmer Do At Glaxosmithkline

* GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies, with statisticians and programmers working at UK and US R&D sites, and worldwide.
* In recognition of the developing sophistication and technical requirements of the programming role, the Clinical Programming department was formed as a standalone department within the broader Clinical Statistics group 18 months ago, covering all phases of clinical drug development and commercialisation in a wide range of therapeutic areas.
* In addition to the group’s activities supporting GSK’s pipeline of drugs, key accountabilities include developing and implementing strategies for programming resourcing using both internal, external, onshore and offshore resource; driving CDISC implementation for the reporting of clinical trials; and identifying and implementing IT solutions to offer further benefit and efficiency for the group’s activities.
* The Principal Programmer acts as a lead programmer for GSK clinical trials, accountable for creating, verifying, and documenting analyses of clinical data while adhering to study protocols, analysis plans and GSK / industry standards.
* Responsibilities:
* Plan and manage programming activities across multiple studies, asset(s), indication or function to deliver all data analysis outputs to agreed timelines and quality, (e.g., analysis datasets, pooled datasets, tables, figures and listings for regulatory or reimbursement submissions and publications).
* Oversee outsourced tasks to third party vendors and ensure their performance meets the agreed timelines, quality and budget requirements established for the project or study.
* Define, develop and embed standards within a function, or therapeutic area in accordance with industry standards
* Responsible for programming and QC across a study/asset including submission activities.
* Review and input into key documents at the project level (e.g. submission documents, clinical reports and publications).
* May author or co-author reporting analysis plans and department level documents (e.g.
* SOPs, working practice document).
* Participate in the design of other study delivery components (e.g. case report forms, study databases).
* Provide tools that add value at study team and functional team level
* Act as key statistical programming contact for internal and external business partners.
* Work with other disciplines outside of the department to solve complex problems.
* Proactively identify, assess and resolve the impact of decisions/actions from other groups.
* Define criteria for assessing alternative solutions and determine the optimal approach.
* Make decisions in the face of unusual and conflicting information.
* Provide broader technical knowledge and expertise (e.g.
* UNIX scripting, computing environments).
* Provide technical advice to other teams and departments.
* Appreciate future direction/wider objectives of project or business.
* Anticipate future challenges.
* Identify recurring problems and initiate process improvement.
* Provide oversight, training and performance feedback to less senior programmers
* Why You

What Does A Clinical Statistical Programmer Do At Inc. Research

* Act as the core project team lead to coordinate and manage all statistical programming activities.
* Serve as the lead programmer to design and specify the overall approach to a projects programming tasks.
* Provide statistical programming liaison to clients and input for Statistical Analysis Plans.
* Create and maintain programming tracking documentation.
* Create, test, and maintain SAS programs for clinical studies.
* Generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan.
* Generate outputs and reports to support other departments.
* Perform validation on computer-generated output to verify accuracy.
* Develop utility SAS macros for use in project programs.
* Performing validation on standard SAS macros.
* Transfer of deliverables.
* Following departmental SOPs, OGs, and relevant regulatory guidelines (e.g.
* ICH

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How To Become A Clinical Statistical Programmer

Most computer programmers have a bachelor’s degree in computer science or a related subject; however, some employers hire workers with an associate’s degree. Most programmers specialize in a few programming languages.

Education

Most computer programmers have a bachelor’s degree; however, some employers hire workers who have an associate’s degree. Most programmers get a degree in computer science or a related subject. Programmers who work in specific fields, such as healthcare or accounting, may take classes in that field to supplement their degree in computer programming. In addition, employers value experience, which many students gain through internships.

Most programmers learn a few computer languages while in school. However, a computer science degree gives students the skills needed to learn new computer languages easily. During their classes, students receive hands-on experience writing code, testing programs, fixing errors, and doing many other tasks that they will perform on the job.

To keep up with changing technology, computer programmers may take continuing education and professional development seminars to learn new programming languages or about upgrades to programming languages they already know.

Licenses, Certifications, and Registrations

Programmers can become certified in specific programming languages or for vendor-specific programming products. Some companies require their computer programmers to be certified in the products they use.

Other Experience

Many students gain experience in computer programming by completing an internship at a software company while in college.

Advancement

Programmers who have general business experience may become computer systems analysts. With experience, some programmers may become software developers. They may also be promoted to managerial positions. For more information, see the profiles on computer systems analysts, software developers, and computer and information systems managers.

Important Qualities

Analytical skills. Computer programmers must understand complex instructions in order to create computer code.

Concentration. Programmers must be able to work at a computer, writing lines of code for long periods.

Detail oriented. Computer programmers must closely examine the code they write because a small mistake can affect the entire computer program.

Troubleshooting skills. An important part of a programmer’s job is to check the code for errors and fix any they find.

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Clinical Statistical Programmer jobs

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Real Clinical Statistical Programmer Salaries

Job Title Company Location Start Date Salary
Clinical Programmer Orbis Data Solutions, LLC King of Prussia, PA Feb 23, 2015 $146,090
Clinical Programmer Orbis Data Solutions, LLC King of Prussia, PA Feb 23, 2015 $140,873
Clinical Programmer Green Key Temp LLC Berkeley Heights, NJ Feb 15, 2016 $140,000
Statistical Programmer Orbis Data Solutions, LLC Woodcliff Lake, NJ Jul 26, 2016 $138,264
Principal Statistical Programmer EMD Serono Research & Development Institute, Inc. North Bergen, NJ Dec 09, 2016 $134,000
Statistical Programmer Lenox Executive Search/Datatemps, LLC Lenox, MA May 07, 2016 $130,000
Principal Statistical Programmer Parexel International Billerica, MA Sep 26, 2016 $130,000
Principal Programmer, Statistical Celgene Corporation Berkeley Heights, NJ May 12, 2016 $130,000
Statistical Programmer Techdata Service Company, LLC. PA Jun 09, 2016 $129,394
Clinical Programmer Inventiv Health Clinical SRE, LLC Pennington, NJ Apr 10, 2015 $128,211
Manager, Statistical Programmer Inc. Research LLC King of Prussia, PA Feb 19, 2016 $125,557
Statistical Programmer II Populus Group LLC Foster City, CA May 30, 2016 $125,220
Statistical Programmer PVR Technologies Inc. Santa Clara, CA Jul 20, 2016 $89,440
Statistical Programmer 2 Quintiles, Inc. Overland Park, KS Oct 24, 2016 $89,093 -
$102,300
Statistical Programmer 2 Quintiles, Inc. Gurnee, IL Sep 01, 2015 $89,093
Statistical Programmer 2 Quintiles, Inc. Overland Park, KS Apr 06, 2015 $89,039
Statistical Programmer FMD K&L, Inc. Fort Washington, PA Jan 15, 2016 $89,000
Statistical Programmer II Pharmaceutical Research Associates, Inc. Medina, MN Jan 12, 2016 $89,000 -
$99,000
Clinical Programmer II Pharmaceutical Research Associates, Inc. Blue Bell, PA Mar 23, 2015 $89,000 -
$99,000
Statistical Programmer-I Clinical Data Solution, LLC Hamilton, NJ Jul 03, 2016 $78,790
Statistical Programmer II Inventiv Health Clinical, LLC Las Cruces, NM Sep 27, 2015 $78,508
Statistical Programmer I Inventiv Health Clinical, LLC Las Cruces, NM Sep 27, 2015 $78,508
Statistical Programmer I Pharmacyclics, Inc. Sunnyvale, CA Aug 26, 2015 $78,263
Statistical Programmer 2 Quintiles, Inc. Durham, NC Jun 29, 2015 $78,000
Statistical Programmer II Inventiv Health Clinical, LLC Indianapolis, IN Aug 05, 2015 $78,000
Statistical Programmer Numbers Only, Inc. Fremont, CA Jul 02, 2015 $78,000
Statistical Programmer Inc. Research LLC Raleigh, NC Jan 15, 2016 $78,000

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Top Skills for A Clinical Statistical Programmer

Sas/GraphAnalysisDatasetsStatisticalAnalysisPlansSas/SqlSASProgramsSafetyCdiscSdtmDataManipulationAdamEfficacyDataManagementFDACRFSummaryTablesPhaseIIIClinicalTrialDataProcFreqProtocolSas/StatQC

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Top Clinical Statistical Programmer Skills

  1. Sas/Graph
  2. Analysis Datasets
  3. Statistical Analysis Plans
You can check out examples of real life uses of top skills on resumes here:
  • Used SAS/STAT and SAS/Graph procedures to create summaries and graphs.
  • Involved in validating and QC of analysis datasets and tables.
  • Implemented statistical analysis plans regarding PK and ECG with biostatisticians.
  • Participated in designing, coding, testing, debugging and documenting SAS Programs and Macros.
  • Trained new bioanalysts on safety issues and how to use safety software.

Top Clinical Statistical Programmer Employers