Principal Statistician, Oncology - US/Canada (Remote)- Sign-on Bonus!
Multiple Locations: Canada • United States
Requisition Number: 1897
Position Title: Principal Statistician
The Worldwide Biostatistics team is an experienced and diverse group of Statisticians/Biostatisticians and Programmers who collaborate together as one team, both via regularly scheduled group meetings to discuss issues, and impromptu one-on-one discussions between colleagues to discuss a particular topic.
We work with a lot of smaller biotech companies, whom often do not have an internal statistician, resulting in our Biostatistician often having the opportunity to provide insight and robust statistical input to the design of protocols and statistical analysis, as well as interact and build relationships with external groups (e.g. DMCs, regulatory agencies, etc.).
As a Statistician at Worldwide, you will have the opportunity to experience a wide range of study designs, phases, and disease areas, allowing you to experience and grow as a Biostatistician.
The Principal Statistician will perform the lead statistician role, lead the development of statistical design and analysis policies and provide expert consultancy across the stats function
Tasks may include but are not limited to:
- Manage the statistics support to one or more projects/sponsor programmes of work, ensuring that needs are fully met by expert and timely statistical consultancy and support.
- Provides expert review of study designs, analysis plans and reports.
- Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology and writing statistical analysis plans.
- Liaise with internal departments, sponsors and other third parties regarding statistical issues and reporting requirements.
- Provide project support to the statistics reporting process through the specification/review of tables, figures and listings shells, writing/review of derived dataset specifications and the formatting of report documents and tabulations.
- Undertake the preparation of final reports, including the production of tables, listings and figures, and report writing.
- Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and their validation.
- Ensure the maintenance of documentation e.g. the description of programs and validation
- Produce ad hoc data summaries when requested during the course of a trial.
- Extract information from the system during the course of a trial e.g. summaries, data listings, study data sets.
- Make statistical contributions to manuscripts for publication / presentation.
- Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation.
- Represent the function externally through attending and participating in external meetings/conferences.
- Facilitate department knowledge of the latest developments in statistical methods, regulations (in particular ICH, FDA, CPMP points to consider efficacy, safety and quality standards) and software applications.
- Lead the development of statistical design and analysis policies.
- Perform lead role in identifying system and process improvements, and to develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.
- Provide support for the bidding process, including contribution to budget review, proposals, bid defence meetings and development of the budget algorithm for stats activities.
- Provide consultancy, mentoring and guidance to statisticians on statistical methodological issues during trial design and analysis of clinical trial data.
- 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 ICH 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
- Hands-on expert level project statistician experienced in providing statistical leadership to projects.
- Expert in a broad range of statistical applications across all phases (I to IV) of Clinical Research with a thorough knowledge of regulatory standards, SAS and other software applications.
- Well developed consultancy and facilitation skills are required 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.
- Experienced professional statistician with Statistics Qualifications (BSc, MSc, PhD or CSTAT).
- Experienced in guiding/mentoring other statisticians
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Principal Statistician, Oncology - US/Canada (Remote)- Sign-on Bonus!
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.
Location_formattedLocationLong: Research Triangle Park, North Carolina US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.