Clinical SAS Project Specialist

Toronto - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Project Management & Services - Academic Bachelor

We’re hiring a Clinical SAS Project Specialist for our client, a global pharmaceutical company, to join their team. This is a permanent position.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

  • Supervises the operational activities of SAS Consultants and coordinates SAS programming deliverables between the Biostatistics, CDM and Medical Safety departments and for external customers at CROs on a per project assignment. Develops and manages timelines and resources for SAS related activities;
  • Responsible for the management of the SAS programming activities for all safety and clinical data systems used at the company. Responsible to produce quality SAS outputs for standard submission work as well as special search criteria for company products;
  • Represents CDM on Company’s cross functional teams to coordinate the retrieval of data via SAS from data systems owned by CDM for the purpose of submission or marketing activities (e.g. NDAs, PSURs, DSMBs, manuscript preparation, annual meetings). Develops deliverables in a variety of formats (e.g. slides, narrative, appendices) to meet the customer needs;
  • Provides an in-depth review of project documentation (e.g. PSURs, manuscripts, clinical reports) to ensure its accuracy and completeness;
  • Responsible for the integration of safety and clinical data across multiple projects as per Company needs. Constructs and owns the library of integrated datasets and surrounding processes;
  • Participates in the up-versioning process for dictionaries such as MedDRA and WHODD as required to update SAS datasets needed for deliverables;
  • Coordinates the activities and participates in the writing, validation and maintenance of SAS programs and macros to generate SAS datasets, spreadsheets, ASCII files, data listings, tables and graphical displays of clinical trial, safety and post marketing data residing in all data systems owned by CDM, Company;
  • Builds and maintains a library of SAS programs and macros and develops surrounding processes;
  • Provides senior level consultation to Biostatisticians at Company for SAS outputs and formatting for Statistical Analysis;
  • Performs and documents Quality Control checks of SAS programming produced by the Biostatistics group, as requested by the Scientific Leader, CDM;
  • Contributes to the design of Case Report Forms (CRFs), providing expertise in the SAS deliverables affected by the set-up of the CRF to the Project Leader, CDM;
  • Contributes to the Statistical Analysis Plan via the review of the SAP and coordination of the production of mock-up table shells, in coordination with the Scientific Leader Biostatistics;
  • Builds a library of standard edit checks in SAS to supplement edit checks in data systems owned by CDM, Company or in datasets received via CROs, looking for trends that could indicate problems with protocol adherence or data issues. Contributes to the implementation of standard operating documents to allow reusability of standards;
  • Coordinates and participates in SAS activities needed to ensure timely database lock (e.g. producing listings for review of data, quality control checks or blinded analyses dataset creation);
  • Develops Case Report Tabulations and associated documentation for submissions using advanced knowledge of CDISC standards;
  • Transforms various formats (e.g. Excel, csv, ASCII) received from both internal and external clients into SAS datasets and transport files;
  • Coordinates with relevant personnel when additional processing (e.g. standard coding) need be applied to the datasets;
  • Reviews the clinical study database for the standardization of SAS variable names and labels;
  • Maintains CDM website and Electronic Data Capture website with updated SAS reports as needed;
  • Provides technical expertise in the SAS system as needed. Trains junior CDM members, operational departments and external customers on reporting and SAS related issues;
  • Develops proposed strategies for the advancement of SAS technology (e.g. interfacing SAS with other reporting tools) at Company and presents to CDM management;
  • Participates in upgrade and integration projects with IS;
  • Works collaboratively with Clinical Data Management, Biostatisticians, Clinical Research, Medical Safety, Regulatory Affairs and Project; Management staff to meet project deliverables and timelines for clinical and safety database statistical programming and reporting;
  • Participates in the SAS user group and initiatives such as CDISC, bringing new ideas to CDM Company management for consideration;
  • Participates in the management of vendor relationships with regards to the SAS application and CROs performing SAS activities for the Company;
  • Defines new SAS programming requirements for new, complex projects based on protocol and disease under study;
  • Utilizes advanced analytical techniques to identify SAS process issues and root causes and determines course of action for more complex activities;
  • Utilizes advanced problem-solving techniques in the assessment and application of best practices for SAS;
  • Offers expert SAS advice in the creation and standardization of CRFs, database objects, edit checks and reports. Is a leader in process improvement efforts;
  • Demonstrates ability to make sound decisions on complex issues related to daily activities and refers contentious issues with recommendations to the next level (e.g. issues that arise from discrepancy management process);
  • Negotiates and manages contracts between CROs or Vendors producing SAS deliverables on behalf of CDM for Company projects;
  • Demonstrates leadership in creation and promotion of an environment of teamwork, clearly communicating the expectations and objectives of the project;
  • In collaboration with Scientific Leader, CDM, develops training modules for the SAS application and processes and conducts training of junior staff members, other operational departments or external clients;
  • Prepares performance appraisals as part of the CDM performance management program for direct reports;
  • Participates in the CDM recruitment program for direct reports, or indirect reports as requested by the Scientific Leader, CDM;
  • Shows initiative in keeping self at the “leading-edge” of their field;
  • Performs all work in accordance with established regulatory requirements ensuring compliance with GCP, GCDMP and CFR 21.11 guidelines. Maintains and further develops and in-depth knowledge of these documents;
  • Coordinates the development of SOP and Work Instructions for SAS programming activities. Ensures compliance to these SODs;
  • Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to;
  • Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually;
  • Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties,
  • Providing coaching, feedback and recognition;
  • Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment);
  • Works as a member of a team to achieve all outcomes;
  • Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values;
  • Performs all work in accordance with all established regulatory and compliance and safety requirements;
  • All other duties as assigned.

About you

  • Bachelor’s degree in a related field required (e.g. Statistics, Computer Science), Masters preferred;
  • 5-7 years of Pharmaceutical/CRO experience required;
  • High level of SAS experience and expertise as demonstrated in previous work;
  • SAS certification and/or A. Stat or P. Stat accreditation are definite assets;
  • Ability to fulfil the accountability of the Consultant, SAS RD8 position;
  • A solid understanding of the Clinical Data Management and Biostatistics processes;
  • Experience cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset;
  • Experience in creating and maintaining a SAS macro-based clinical reporting system to generate clinical trial tables, listings and graphs;
  • Understanding of systems development life-cycle model in a comprehensive SAS macro-based reporting environment;
  • In depth understanding of relevant safety and efficacy ICH guidelines as well as relevant clinical trials regulations;
  • In depth understanding of CDISC standards is required;
  • Experience with clinical study database and safety database (e.g. Oracle Clinical) is desired;
  • Competent with computer software packages (i.e. proficient in Microsoft Office applications, Internet, Adobe Acrobat Exchange, and relational databases);
  • Strong interpersonal and verbal/written communication skills;
  • Demonstrated effective organizational and time-management skills. Ability to manage multiple priorities in an efficient manner;
  • Demonstrated ability to work independently and as part of a team.

What we offer

Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you, from submitting your resume, to coordinating interviews, to extending offers, and assisting with on-boarding. Let us get you going so you can get on with the job.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB259623
  • Location: Toronto
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branch: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Project Management & Services
  • Closing date: Monday, May 4, 2020
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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