Team Leader OR Manager Statistical Programming - Hungary, Mexico, Poland, US/Canada

Multiple Locations: United States • Hungary • Canada • Poland

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Requisition Number: 4842

Position Title: Team Leader, Statistical Programming

External Description:

Who we are 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. 

We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. 

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.  

What Global Programming does at Worldwide

The Worldwide team is an experienced and diverse group of Programmers who collaborate together as one, both via regularly scheduled group meetings to discuss issues, and impromptu one-on-one discussions between colleagues to discuss a particular topic. 

The Team Leader, Statistical Programming manages a statistical programming team, provides leadership of technical standards within the programming function, and leads continuous improvement in the programming function’s operating systems.  

RESPONSIBILITIES:          
Tasks may include but are not limited to:

  • Manage the programming resource for a designated set of projects, involving the planning and allocation of project work, raising and helping resolve resource issues for the statistical programming function.
  • Proactively manage and develop the performance of statistical programmers through performance management, resource review and planning, capability, disciplinary, training & development to meet the needs of the business.
  • Perform the lead programming role, responsible for planning and delivery of all study programming activities including programs for edit checks, derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and program validation.
  • Ensure the maintenance of documentation e.g., the description of programs and validation
  • Produce ad hoc data summaries when requested during a trial.
  • Liaise with internal departments, sponsors and other third parties to ensure all delivery requirements fulfil client needs.
  • Extract information from the system during a trial e.g. summaries, data listings, study data sets.
  • Provide project support to the statistics reporting process through the specification of tables, figures, and listings shells, writing of derived dataset specifications and the formatting of report documents and tabulations.
  • Manage identifying system and process improvements, and to develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.
  • Lead development and maintenance of in-house programming standards in line with the above quality standards and regulations.
  • Provide support for the bidding process, including contribution to budget review, bid defense meetings and development of the budget algorithm for stats programming activities.
  • Provide consultancy, mentoring and guidance to Programmers and Statisticians on programming and associated software support.
  • Maintain a high level of expertise in: SAS applications (e.g., BASE, MACRO, GRAPH, ODS, SQL), other software applications (e.g. Excel, Visual Basic, Word) and regulatory standards in computer systems, systems validation, Good Clinical Practice, clinical/ statistical reporting and regulatory submission requirements.
  • Assist with Quality Assurance and Audit requirements
  • Assist the Director of Biostatistics with all other aspects of the job as required
  • Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant GCP standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).

OTHER SKILLS AND ABILITIES:

  • The job holder must be computer literate and numerate with a proven ability to adapt to various computer systems
  • The job holder should have well developed consultancy and facilitation skills together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating, and influencing, embracing innovation and change, building capability and participative leadership.

 
REQUIREMENTS:

  • Educated to degree level.
  • The jobholder has advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Tabulate, Proc Report and ODS.Good working knowledge in SAS/Graph, Proc SQL.
  • Strength of knowledge across a range of data management (e.g. data validation, audit trails, laboratory data transfer and coding dictionaries, electronic data capture) and statistical (e.g. data restructuring, data summary, analysis and reporting) applications.
  • Experienced in guiding/mentoring other programmers

Why Worldwide 
 

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.   

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

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Employment Type: Regular

Community / Marketing Title: Team Leader OR Manager Statistical Programming - Hungary, Mexico, Poland, US/Canada

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.

 Worldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendors

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© Worldwide Clinical Trials 2021

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.