Principal Statistical Programmer

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 define.xml 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.