Principal Statistical Programmer - Cambridge, United States - Prometrika LLC

Description

Job Description

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.

RESPONSIBILITIES

Provide subject matter expertise in the design and development of clinical trials, protocols and case report forms. Offer technical support and expert advice to internal and external sponsors. Provide a broad range of leadership and influencing capabilities in the support of ongoing clinical studies requests for statistical and non-statistical analyses, including the design and testing of program logic, coding programs, program documentation and preparation of programs. Implement and execute programming and project standards in accordance with the Statistical Analysis Plan. Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Act as a liaison between clinical management, subcommittees and project teams as needed.

The Principal Statistical Programmer will:

• Use efficient programming techniques to produce and /or QC derived datasets tables, figures, and data listings
• Design or write program specifications based on consultations with Statistical Programming and Biostatisticians
• Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs
• Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables
• Create statistical analysis outputs to be used in support of final reports, abstracts, posters, manuscripts and other clinical publications; support systems to produce electronic regulatory submissions
• Assist in establishing standardized programming procedures and work instructions
• Develop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation/compliance activities
• Develop and maintain clinical processing work flow systems
• Assist in the development of client proposal documents
• Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities
• Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets
• Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate
• Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.)
• Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation
• When needed, interact with regulatory agencies regarding specifications for electronic submission, and direct/develop statistical programming electronic submission deliverables
• Monitor project resourcing, project budgets, and identify changes in scope
• Be accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables
• Assist project teams in the resolution of problems encountered in the conduct of their daily work
• Assist in the production and QC of analysis plans, and produce and QC TLF mock-shells, derived dataset specifications, programming specifications and other process supporting documents
• Proactively participate in and/or lead process/quality improvement initiatives
• Provide consultancy to internal and external sponsors with regard to statistical programming tasks
• Ensure the statistical programming system, processes and deliverables are aligned with relevant regulatory requirements such as clinical study reporting (e.g., ICH E3), electronic records handling (e.g., Chapter 21 of the US Code of Federal Regulation – Part 11), and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards)
• Maintain visibility to sponsors to ensure that expectations are being met
• Create standard macros and applications to improve the efficiency of the department
• Assess technology and processes to facilitate best practices, increase quality, efficiency, and productivity
• Consult with sponsors on technical/regulatory issues
• Represent PROMETRIKA at sponsor marketing and technical meetings
• Represent Statistical Programming on cross-functional technical initiatives
• Create complex analysis dataset specifications involving statistical derivations, for clinical trials
• Assist in updating/writing PROMETRIKA standard operating procedures (SOPs)
• Develop tools in SAS for data analysis and reporting that comply with regulatory requirements
• Develop specifications (e.g., metadata files), annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards
• Create files from metadata files for SDTM and ADaM
• Convert data received in other formats to SAS datasets

EDUCATION

• Bachelor's degree in Computer Science, Mathematics, Statistics, Life Sciences or a related field is required

EXPERIENCE

• Minimum of 10 years of experience of experience using SAS in analyses of clinical trials data
• Prior exposure to CDISC (SDTM and ADaM) is a plus

SKILLS

• Must have expertise in SAS/BASE, SAS/STAT and knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS
• Knowledge of SDTM, ADaM, FDA and ICH guidance
• Understanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems
• Good organizational skills across individual projects, and managing own and team work loads. Ability to independently and effectively organize, manage and complete multiple assignments with challenging timelines
• Consistent experience as a lead statistical programmer on several concurrent projects
• Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions
• Strong mentoring skills as shown by leadership of projects and if applicable, junior team members
• Excellent analytical skills
• Proven ability to learn new systems and function in an evolving technical environment.
• Ability to negotiate and influence to achieve results
• Good presentation skills
• Good business awareness/business development skills (including financial awareness)
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial
• Work effectively in a quality-focused environment
• Knowledge of other programming languages and database management software packages is a plus

Physical Requirements

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.