Job Description:

Biostatistician

Job Locations

US-MD-Baltimore | US-MA-Cambridge

Summary of Major Responsibilities

The Biostatisticianwill be responsible for designing clinical study protocols and analytical validation plans, performing statistical analyses, and writing study reports for diagnostic assay development and clinical trials. This position will use strong statistical skills, a solid scientific background, and a high level of professional maturity to consistently meet deadlines under pressure.

This position can be located in either Baltimore, MD or Cambridge, MA.

Essential Duties and Responsibilities

Provide statistical and programming support through analysis and simulations to assist with statistical needs in the clinical and analytical validation of diagnostic assays.
• Manage and analyze clinical trials and perform statistical analyses.


• Interpret and communicate study results within and between teams.


• Write high quality study reports.


• Assist with the preparation of regulatory documents and provide responses to statistical issues arising in regulatory or external partners.


• Draft statistical analysis plans (SAPs) and tables, listings, and figures (TLFs) to ensure quality and compliance with specifications.


• Partner with the clinical operations and data management teams to support data management-related responsibilities; including, but not limited to, trial start-up, CRF development, external data transfer review, and dataset specification review.


• Build and maintain strong collaboration with cross-functional teams by helping with study plans and protocol development, data preparation, programming, analysis, and presentation of results and decision framework.


• Contribute to the long-term growth strategy of the product development team through participation in cross-functional workstreams and contributions to the development of statistical methodologies applicable to new diagnostic assay development.


• Effective communicator with ability to maintain open communication with team members, managers, and customers.


• Ability to integrate and apply feedback in a professional manner.


• Ability to prioritize and drive to results with a high emphasis on quality and attention to detail.


• Ability to work as part of a team.


• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.


• Support and comply with the company's Quality Management System policies and procedures.


• Maintain regular and reliable attendance.


• Ability to act with an inclusion mindset and model these behaviors for the organization.


• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.

Qualifications

Minimum Qualifications

• Ph.D. in Biostatistics, Statistics, or a related field with a significant quantitative base; or Master's Degree in Biostatistics, Statistics, or field as outlined in the essential duties and 2 years of relevant experience as outlined in the essential duties in lieu of Ph.D.


• Excellent communication and writing skills, with a demonstrated ability to clearly explain complex technical details.


• Demonstrated ability to utilize a high level of professional maturity to consistently meet tight deadlines under pressure.


• Strong programming and computing skills with fluency in programming languages, such as R, SAS, Python, and/or Perl.


• Demonstrated ability to perform the essential duties of the position with or without accommodation.


• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Experience with clinical trials and vendor oversight of statistical deliverables.


• Experience working with protein assay and molecular assay, such as Next-Generation Sequencing (NGS).

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.