Main Responsibilities and Required Skills for Statistical Programmer
A statistical programmer is a professional who creates algorithms and tools for collecting, analyzing, and interpreting statistical information. They design and implement experiments, analyze data sets, and develop models and simulations. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Statistical Programmers.
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Main Responsibilities of Statistical Programmer
The following list describes the typical responsibilities of a Statistical Programmer:
Adhere to
Adhere to all aspects of the SDC's quality system.
Anticipate
Anticipate risks to avert need for study level escalations.
Apply
Apply appropriate statistical methods for data analysis.
Assess
Assess the quality and consistency of analysis data and performs cross-study analyses.
Assess the quality of analysis data and performs cross-study analyses.
Assist in
Assist in developing, revising, and maintaining.
Assist in developing SDTM data mapping specifications.
Assist in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies.
Assist in the development of SDTM aCRF and specifications.
Assist in the review of GSI Policies, SOPs and other controlled documents.
Assist programming management on resource allocation.
Assist with interviewing and selection of potential candidates.
Assist with the transfer of deliverables.
Assure
Assure deliverable quality and compliance with departmental SOPs and good programming practices.
Attend
Attend and actively participate in personal development courses as required.
Begin
Begin to understand how to put together and update programming specifications.
Carry out
Carry out programming, validation and documentation as required.
Coach
Coach, support and mentor new employees.
Collaborate with
Collaborate effectively with project team members.
Collaborate with our statisticians in the calculation of weights for survey data.
Complete
Complete programming and validation of CDISC SDTM and ADaM datasets.
Complete project programming.
Conduct
Conduct effective internal meetings (appropriate in format, frequency and attendance).
Conduct statistical analysis on data that uses complex survey designs and generation of reports.
Consult
Consult on operational topics with clients.
Contribute to
Contribute ideas and thoughts towards the optimization of standard operating procedures.
Contribute to strategic initiatives.
Contribute to the continuous improvement of Programming Environment.
Contribute to the development of analysis and reporting standards for HTA dossiers.
Contribute to the development of best practice to improve quality, efficiency and effectiveness.
Contribute to the development of standard operating procedures for statistical programming.
Contribute to timely and quality programming documentation at study level.
Contribute towards technical solutions.
Convert
Convert specifications into SAS code to generate datasets and tables, Listings, and figures outputs.
Coordinate
Coordinate programming activities.
Create
Create Biostatistics deliverables that follow the protocol and SAP.
Create Define XML, Define PDFs, and Reviewers Guides.
Create randomization scheme for clinical studies as needed.
Create / Reviews derived dataset specifications and the related analysis datasets.
Create SDTM and ADaM define.xml files.
Create SDTM mapping and datasets.
Create SDTM mapping specifications and ADaM data specifications.
Determine
Determine and develop approaches to meet the project requirements.
Develop
Develop and deliver training.
Develop and maintain data set specifications.
Develop and maintain the infrastructure for project files of SAS datasets and SAS code.
Develop an expertise within a therapeutic area or standard tool for Statistical Programming function.
Develop complex conditional logic.
Develop define.xml and create a table of contents of programs for regulatory submissions.
Develop define.xml, study data reviewers guide and analysis datasets reviewers guide.
Develop listing and table specifications with study Biostatistician.
Develop or review SDTM aCRF and specifications, ADaM specifications.
Develop SAS code or macros for preparing, processing and analyzing clinical data.
Develop SDTM mapping documents, ADaM Specifications.
Distribute
Distribute relevant information in advance.
Document
Document changes to SAS code, programs, and specifications.
Ensure
Ensure adherence to high quality programming standards in their daily work.
Ensure adherence to programming guidelines.
Ensure appropriate documentation and QC documentation for their deliverables.
Ensure high quality deliverables.
Ensure minutes are promptly and accurately distributed.
Ensure programmatic traceability from data source to analysis / modeling result.
Ensure programming deliverables are reproducible, defendable and inspection ready at any time.
Ensure proper project planning.
Ensure quality of Deliverables.
Ensure quality of personal work and the work of the team when acting as a Lead Programmer.
Ensure SOP compliance programming across team.
Ensure timely delivery of outputs to meet study timelines and quality expectations.
Follow
Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
Follow current SDTM standards and current ADaM Implementation Guides.
Give
Give input to the data validation plan.
Help
Help drive others to work across global & functional boundaries.
Identify
Identify potential issues in study documentation and proposes solutions.
Identify opportunities and develop tools to improve team efficiency.
Identify opportunities to improve the methodology and provide practical solutions for problems.
Identify study priorities and communicate effectively with project team and management.
Implement
Implement strategic initiatives.
Import
Import, clean, and transform data.
Integrate
Integrate database from multiple studies or sources.
Interact
Interact with Data Management and Biostatics staff and SP team members.
Keep
Keep project team members informed of programming progress and issues requiring their attention.
Lead
Lead design / development of SAS macros and other utilities to expedite SAS programming activities.
Lead efforts to resolve complex statistical programming issues or problems.
Lead programming deliverables for multiple studies.
Lead projects with higher level of complexity / challenges / difficulties.
Lead studies or portions of studies from a programming perspective.
Lead team meetings when appropriate.
Maintain
Maintain and manage a project plan including resource forecasting.
Maintain well organized, complete, and up-to-date project.
Manage
Manage and administer user access and security for emerging technology as required.
Manage customer relationships.
Manage / delegates data quality issue resolutions.
Manage project budget and resource requirements.
Manage project budgets and tracks project specific performance metrics.
Manage resources efficiently across multiple projects to maximize synergies.
Manage statistical programming timelines, budgets, and client expectations.
Maximize
Maximize programming efficiency with use of tools, technical expertise, and lead experience.
Mentor
Mentor junior level statistical programmers.
Mentor other team members in department procedures and develop technical expertise.
Modify
Modify and write SAS macros.
Oversee
Oversee progress of programming activities.
Oversee team with same expectations.
Participate in
Participate in statistical programming project bidding or bid defense meetings.
Participate in statistical program validation and quality control activities.
Perform
Perform activities and provide technical expertise in support of reporting data from clinical trials.
Perform assigned SAS programming required for clinical trial analysis and reporting.
Perform assigned statistical programming required for clinical trial analysis and reporting.
Perform interviews for selection of potential candidates.
Perform quality control (QC) review of these documents prepared by others.
Perform SDTM CRF annotation (aCRF) or QC activities on aCRFs generated by others.
Perform statistical programming activities.
Perform the role of the Lead Statistical Programmer.
Perform transfer of the archived files to the clinical trial sponsors.
Perform work with minimal supervision.
Plan
Plan and programming specifications.
Plan client deliverables and manage project budgets.
Prepare
Prepare ADaM dataset specifications as per required.
Prepare summarized information for clinical study team members.
Present
Present and share knowledge at department meetings.
Prioritize
Prioritize personal workload and that of teammates.
Process
Process clinical data required for statistical analysis.
Produce
Produce and maintain the technical database standards and Programming Specification documents.
Produce reports and deliverable files for clients.
Produce timely statistical analyses of clinical data per protocols and Statistical Analysis Plans.
Program
Program analysis database manipulations and transfer.
Program data cleaning checks, as necessary, to facilitate Data Management's data cleaning activities.
Program / validate SDTM datasets including define.xml and SDTM reviewer's guide.
Provide
Provide consistency and quality assurance across various studies.
Provide feedback to management on the development potential of staff to assist in staff development.
Provide input into assessments of resource requirements on regular basis.
Provide input into the design and development of project plans.
Provide input to and participate in Programming and Biometrics meetings.
Provide input to statistical analysis plans.
Provide programming algorithm support as needed.
Provide statistical programming expertise for project teams.
Provide statistical programming project leadership to key project dimensions.
Provide statistical programming support to clinical trials.
Provide technical expertise and leadership to the department.
Provide technical expertise to support data reporting for clinical trials.
Provide technical planning to include overseeing the set-up of key macros and SAS programs.
Provide training and mentoring to SP team members and Statistical Programming department staff.
Provide training and technical guidance to Statistical Programmers.
Receive
Receive similar job offers.
Recognize
Recognize inconsistencies and initiate resolution of data problems when necessary.
Recognize inconsistencies and initiates resolution of data problems.
Recognize when negotiating skills are needed and seeks assistance.
Recommend
Recommend potential trainings.
Represent
Represent programming group in the SMT (Study member team) meetings.
Represent Statistical Programming at internal and client meetings.
Represent statistical programming on process improvement activities.
Respond
Respond to QA and client audits and support qualification audits.
Review
Review and interpret Statistical Analysis Plans and provide comments for assigned projects.
Review and provide input to statistical analysis plans and TLF specifications.
Review clarify and process change requests for the applications.
Review draft and final production runs for project to ensure quality and consistency.
Review, maintain, and approve protocol specific documents as necessary.
Review SAP and prepare mock shells as required.
Review the clinical study protocol and clinical study report as assigned.
Review the Statistical Analysis Plan in preparation for programming the planned analyses.
Study
Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets.
Supervise
Supervise / manage external vendors and contract programmers.
Support
Support Data Management in data set creations / transfers, integrity checks, and quality audits.
Support the implementation / validation / improvement of existing software.
Take
Take initiative and can be counted on to get the job done, with integrity.
Take steps to understand and appreciate the roles, skills and strengths of others on the team.
Train
Train and mentor new and junior programmers.
Understand
Understand and compile with Standard Operating.
Use
Use and promote the use of established standards, SOP and best practices.
Use data steps and PROC SQL to combine and aggregate data.
Use internal macros to automate study deliverables.
Use SAS or other software to generate summary tables, data.
Utilize
Utilize and contribute to the development of standard departmental SAS macros.
Utilize and share innovative approaches to build and maintain a competitive advantage.
Utilize the infrastructure for project files of SAS datasets and SAS code.
Validate
Validate SDTM and ADaM datasets and create define.xml file.
Work with
Work closely with data management team.
Work to ensure that outputs meet quality standards and project.
Work to ensure that outputs meet quality standards and project requirements.
Work with and leverage the best and brightest minds in the industry.
Work with statisticians and programming leads to ensure clear specifications for their programmed.
Work with vendor staff to characterize and resolve issues related to data analysis.
Write
Write program specifications based on consultations with the biostatistician.
Write statistical sections of integrated reports.
Write working instructions, system and user manuals.
Most In-demand Hard Skills
The following list describes the most required technical skills of a Statistical Programmer:
Graph
ICH
FDA
CDISC SDTM
Regulatory Guidelines
GCP
SAS Macros
Analysis Activities
CFR
Clinical Trial Design
Medical Data
Process Scientific
SDC's Data Integrity
Clinical Trial Environment
CDISC Standards
Clinical Data
Life Sciences
Macro
Pharmaceutical
Reporting
Biological Sciences
Design
Electronic Data Submission Requirements
Clinical Trial
Most In-demand Soft Skills
The following list describes the most required soft skills of a Statistical Programmer:
Written and oral communication skills
Interpersonal skills
Organizational capacity
Time-management
Problem-solving attitude
Leadership
Analytical ability
Present problems
Presentation
Attention to detail
Multi-task
Assist with projects and initiatives
Work with others effectively
Implement solutions quickly
Work independently with little direction
Delegate
Initiative
Prioritize work to meet tight deadlines while maintaining high standards
Manage timelines
