Statistical Programmer Job Description
Statistical programmer
provides clinical data management and biostatistical programming support for various phases of clinical studies (reference International Council for Harmonisation (ICH) E6 R2) whichleads to generation of high-quality, reliable, and statistically sound data from clinical trials.
Statistical Programmer Duties & Responsibilities
To write an effective statistical programmer job description, begin by listing detailed duties, responsibilities and expectations. We have included statistical programmer job description templates that you can modify and use.
Sample responsibilities for this position include:
Assisting the Director of Biostatistics and Data Management in preparing study protocols and reports which may include calculating sample size calculations and generating randomization schedules
Writing statistical programs using SAS per requests from internal or external clients
Verification and validation of statistical programs, statistical results and datasets for each assigned project
Reviewing the statistical analysis plan (SAP)
Performing quality checks (through edit specifications) on clinical datasets
Maintaining other project administration files including protocols, annotated case report forms (CRFs), statistical analysis plan and project related memorandums
Performing quality control of analysis datasets
Maintaining good documentation regarding location of files and descriptions of all datasets pertaining to projects
Training and mentoring of new and junior staff members on working practices and processes
Assisting in development of Standard Operating Procedures (SOPs)
Statistical Programmer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Statistical Programmer
List any licenses or certifications required by the position: SAS, STAT
Education for Statistical Programmer
Typically a job would require a certain level of education.
Employers hiring for the statistical programmer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Computer Science, Statistics, Mathematics, Biostatistics, Science, Life Science, Life Sciences, Education, Technical, Math
Skills for Statistical Programmer
Desired skills for statistical programmer include:
WSOPs/Guidelines/System Life Cycle methodologies
ICH-GCP
SOPs/Guidelines
Programming and reporting process
Statistics
Clinical drug development process
Biostatistics
Medical arenas
Any other applicable local and international
SAS/STAT
Desired experience for statistical programmer includes:
Develop programming specifications for analysis datasets, pooled, datasets and deliverables
Review and provide feedback on statistical analysis plan, output shells, CRF, edit checks and other relevant trial documents
Develop and comply with project/study programming standards and specifications following internal guidelines
Program according to specifications, analysis datasets, pooled datasets, listings, and figures for clinical trials and submission activities
Provide input as required at all meetings, discussions, and activities covering aspects of Statistical Programming on trial level activities
Track clinical trial milestones for statistical programming deliverables
Statistical Programmer Examples
1
Statistical Programmer Job Description
Job Description Example
Our company is searching for experienced candidates for the position of statistical programmer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for statistical programmer
- Work with non-standard datasets and databases to create study-specific Analysis datasets
- Write and maintain programs to create Tables, Listings and Graphs according to Statistical Analysis Plan
- Work closely with Pharmacometrician to create high quality data specifications
- Use statistical and graphical tools extensively to identify data issues and correct them
- Create datasets for Population PK Analysis
- Create PC and PP SDTM datasets according to specifications
- Ensure all written programming code meets internal and regulatory standards
- Write reusable code to automate routine tasks
- Provide input and participate in development of Processes and SOPs
- Work as part of consulting overall team (often global) to meet client deliverable requirements
Qualifications for statistical programmer
- Demonstrated ability to work in global teams, , manage projects independently
- Must conduct activities in compliance with all relevant regulations such as ICH, GCP, and CFR, all Shire policies and procedures
- Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise
- Ensure timelines and adequate quality of data review reporting deliverables for assigned trials
- Follow processes and adhere to company- and project-specific standards, Health Authority requirements
- Comply with project/study programming standards and specifications following internal guidelines
2
Statistical Programmer Job Description
Job Description Example
Our company is searching for experienced candidates for the position of statistical programmer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for statistical programmer
- Participate as required at all meetings, discussions and activities covering aspects of data review reporting on trial level activities
- Maintain efficient interfaces with internal and external customers
- Support creation and validation of esubmission requirements
- 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
- Provide programming support for simple presentations and basic statistical ad-hoc requests
- Create and/or validate ADaM data sets
- Ability to fill Primary Statistical Programmer role on projects
- Apply standard tools developed for the study or project
- Support to the development, validation, maintenance and enhancement of global macros training on the same
- Ensure quality of personal work and the work of the programming team when acting as a Biometrics Project Manager and Lead Programmer meeting completions dates with minimal supervision
Qualifications for statistical programmer
- Advanced technical expertise in databases, EDC platforms, data imports/integrations
- SDTM, ADaM and TLF experience required
- Demonstrated skills in using additional software tools and applications
- Competent in written English
- Experience working with systems used within the Clinical Trial process (e.g., SAS)
- Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, ) and implications for the department
3
Statistical Programmer Job Description
Job Description Example
Our growing company is looking to fill the role of statistical programmer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for statistical programmer
- Deliver high quality statistical programming deliverables for all assignments that consistently meets study timelines, quality standards, sponsor and/or contractual requirements
- Ensure high quality deliverables for assigned team members by performing quality control and review of programming outputs for accuracy and consistency
- Create analysis dataset specifications (ADaM or client-specific) to an exceptional standard of quality and accuracy
- Create, document and validate project/study-macros at the table, listing and figure level
- If desired, may supervise less-experienced statistical programmers carrying out line management responsibilities
- Delivers code that requires minimal review and cross checking from a more senior individual and should use advanced programming methods, such as macros or reusable functions, advanced SQL
- Programs tabulation datasets and statistical analyses (via analysis datasets, tables, figures, listings, ) using an appropriate statistical analysis systems
- Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents
- Provide relevant training and mentorship to staff and project teams as appropriate
- Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request
Qualifications for statistical programmer
- SAS Certification desirable
- Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, in accordance with existing policies and standards for application to specific problems or tasks
- Knowledge of pharmaceutical clinical development
- Competent in written and oral English and in Polish
- Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR
- Assist in the coordination of project start-up activities, including Unix/PMED project area set-up
4
Statistical Programmer Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of statistical programmer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for statistical programmer
- Gain specific knowledge about the clinical data collected for the trial
- Transform specifications in the Trial Statistical Analyses Plans (TSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report
- Provide support for the electronic submission to regulatory agencies worldwide
- Provide fully documented and tested programs utilizing project or substance data bases in support of integrated reporting for regulatory agencies, Investigator Brochures (IB)
- Statistical Programmer III is responsible for the preparation of data utilized by Risk Analysts and Statisticians, the implementation of data models and scorecards, and the execution of User Acceptance Testing of internal systems and third-party deliverables
- Potential supervision of less-experienced statistical programmers carrying out line management responsibilities
- Define and edit mock tables, listings and figures (TLFs) and analysis dataset specifications
- Design and develop new work instructions (WIs) and updates to existing WIs
- May coordinate efforts to standardize WIs or processes across studies
- Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards
Qualifications for statistical programmer
- 7 plus years Pharmaceutical/CRO industry and/or relevant experience as a SAS programmer supporting clinical trials for regulatory submissions
- Bachelor’s degree or higher in a computing or science related field
- Expert knowledge of CDISC terminology and architecture for both SDTM & ADaM
- Able to develop programming tools to efficiently create study specific SDTM and ADaM data sets
- Sound technical skills and communication ability, both oral and written
- Competent in SAS programming
5
Statistical Programmer Job Description
Job Description Example
Our growing company is looking to fill the role of statistical programmer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for statistical programmer
- Monitor project resourcing, project budgets, and identify changes in scope activities
- Ensure quality control (QC) on all process and technical activities related to derived dataset, tables, listing, and figure programming in accordance with corporate quality standards
- Develop data management plans
- Design, develop, and maintain data mappings, data rules, and data transformations to populate data warehouse with source data
- Produce data and unit dictionaries, edit checks, derivations, standard, and custom reports
- Generate datasets needed for resolution of discrepancies
- Communicate with local and external teams throughout the QC process to provide the most accurate and complete endpoint datasets needed for reporting requirements
- Ensure compliance with study documents and departmental procedures
- Verify completeness of study deliverables prior to release
- Make, document and validate data programs, pipelines, distribution plans, and storage
Qualifications for statistical programmer
- Experience of working with clinical trials either in a CRO, Pharmaceutical or Biotechnology organization
- Experience working with SAS used within the Clinical Trial process
- Excellent understanding of clinical trial practices, procedures and methodologies is preferred
- Extensive knowledge and experience in prescription data, emr data, managed care data (plan / payer data), medical claim data, patient longitudinal data, healthcare affiliation data, promotional data
- Bachelor’s degree in Computer Science with minimum 7 years of experience
- OR Master’s degree in Computer Science with 5 year of experience