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ERT Lead Biostatistician in Rochester, New York

BASIC PURPOSE

The Lead Biostatistician is responsible for staff management, and directing and managing services for client projects to assure high quality and on-time delivery as well as conducting statistical analysis, and validating and interpreting statistical analysis results.

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.

Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Manage designated statistics staff, which includes:

  • Mentoring and defining career paths by developing core competencies

  • Ensuring proper training is executed and documented

  • Conducting reviews of system set-ups and documents to ensure high quality of deliverables in accordance with quality standards and SOPs

  • Coordinating routine status meetings to facilitate communications, monitor workload, and provide forecasting guidance

  • Work with Biostatistics Operations Manager to manage timelines and client commitments and ensure on-time delivery

  • Assist with client calls and meetings, as required, to discuss statistical outputs.

  • Provide statistical programming support (programming, validation, and documentation) of cardiac safety and/or imaging deliverables.

  • Prepare and/or validate tables, figures, and listings for as outlined in statistical analysis plans.

  • Prepare programs and outputs to support reader variability reports.

  • Modify existing analysis programs to fit individual study requirements.

  • Create new SAS and/or R programs and macros that meet project requirements.

  • Participate in data analysis and interpretation for study documents such as reader variability analysis reports and cardiac safety reports.

  • Preparation of analysis datasets for blinded interim analysis.

  • Assist in post-processing data activities including data QC, completing IIRV reports, and cardiologist consistency checks.

  • Ensure compliance with timely training completion/documentation.

  • Provide written reports detailing the evaluation and interpretation of statistical analysis results including central tendency analysis, concentration-QTc analysis, categorical analysis, and variability analysis.

OTHER DUTIES AND RESPONSIBILITIES:

  • Support research programs and provide research results to the Principal Biostatistician.

  • Contribute to manuscripts and/or scientific presentations through ongoing support of research programs

  • Develops metrics and generates quality control reports to optimize the performance of products and/or individual projects

  • Develop process improvements to increase overall operational efficiency

  • Contribute to a respectful and inclusive work environment and exhibit ERT behaviors and communication expectations

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.

QUALIFICATIONS AND SKILLS NEEDED:

Education:

  • Master’s degree in biostatistics, statistics or related field

Experience:

  • At least 5+ years of previous experience in statistical modeling for clinical trials. Experience with concentration QT modeling preferred

  • Proficiency in SAS programming including SAS base, SAS macro language, SAS SQL and SAS Stat.

  • Familiarity and experience with regression, linear mixed-effects modeling, and advanced data display.

  • Effective written and oral communication skills for presenting technical concepts to a multidisciplinary audience.

  • Computer competencies to include Microsoft Outlook, Word, and Excel.

  • Ability to manage multiple tasks and shifting priorities.

  • Excellent organizational, interpersonal, time management and prioritization skills.

  • Ability to learn quickly, function independently, and handle increasing levels of responsibility.

  • Strong R programming skills preferred.

ERT is a growing and rewarding place to advance your career, especially for those who are passionate about finding solutions that improve lives – or save lives – for millions of people around the world. Our success starts with caring and collaborative people, from the recent college grad who’s just getting started to the seasoned professional with a wealth of knowledge, skills and experience. Together, we’re making a difference.

ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Hours: M-F

External Company Name: eResearch Technology

Telecommute: No

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