Principal DMC Biostatistician

Cytel - USA & APAC
Cambridge, MA
JOB DESCRIPTION

The Principal DMC Biostatistician is expected to have a thorough understanding of advanced statistical methods and develop an understanding of innovative statistical approaches (e.g., simulations, adaptive designs, Bayesian statistics). The Senior Biostatistician is also expected to have a thorough understanding of the DMC process and may assume the functional lead role within a designated DMC project team, involving facilitation of DMC meetings, awareness and active monitoring of project budgets, hours budgeted/spent, timelines, and will be actively contributing to systematic regular project status reviews.

We offer structured peer mentoring and technical and management career development opportunities with exposure to clinical trials in many disease indications with a range of statistical methods across drugs, biologics, devices, and vaccines.

RESPONSIBILITIES

  • Develop and review input for DMC activities (charter, statistical analysis plan, mock shells, specifications, analysis, programming and validation, DMC meetings, meeting minutes).

  • Review and perform oversight of analysis plans, statistical analyses, outputs, and datasets provided by another vendor.

  • May serve as functional lead on DMC project teams.

  • Liaise with client/DMC for clarification on any technical decisions and propose most efficient, successful solutions.

  • Interact and coordinate with client staff and DMC members.

  • Participate in project team meetings and DMC meetings on a regular basis.

  • Provide statistical advice in project team setting.

  • Identify risks to project deliverables and timelines, develop and implement the mitigations for these risks.

  • Stays current regarding requirements to ensure quality control and audit readiness of all assigned biostatistics deliverables as well as accuracy and reliability of statistical analysis results.

  • Accurately review and report project forecasting and actual hours as scheduled per agreed scope for biostatistics tasks.

  • Understand and follow all relevant SOPs.

  • Understand and adhere to project specific clinical protocols.

  • Mentor Biostatisticians.

  • May coordinate activities of other personnel.

QUALIFICATIONS

  • Master’s degree or PhD in Biostatistics, Statistics, or related field.

  • With PhD, a minimum of 5 years of industry experience, with an MS a minimum of 7 years of industry experience.

  • SAS programming skills; R a plus.

  • Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.

  • Prior DMC experience required.

Posted 2026-01-18

Recommended Jobs

Digital Music Production Teacher (Part Time, In-Person)

Concorde Education
Cambridge, MA

General Responsibilities: Under the supervision of the Director of Educational Development, plans and facilitates collaborative and interactive digital music production instructional sessions.   …

View Details
Posted 2026-01-21

Plant Electrical Engineer

Knowhirematch
Springfield, MA

Plant Electrical Engineer Springfield, MA area Description: This is a unique opportunity in an upscale town outside of Springfield close to Vermont and New Hampshire with nearby colleges. …

View Details
Posted 2025-04-29

Sr. Front-end Developer

Two95 International Inc.
Boston, MA

Title: Sr. Front-end Developer Location: Boston, MA (Some remote flexibility is an option as well) Duration: 2+month with extensions (conversion to full-time is an option as well) Int…

View Details
Posted 2025-08-09

Communication Dispatcher II

University of Massachusetts Boston
Boston, MA

General Summary:  The Dispatcher II position is an entry level, uniformed non-sworn, support position for the University Police Department. Under general supervision of the Dispatch Supervisor or the…

View Details
Posted 2025-07-10

Entry Level Sales Representative

C-4 Analytics
Wakefield, MA

Entry Level Sales Representative: C-4 Analytics C-4 Analytics, a leading digital marketing company, specializes in boosting automotive dealership performance by increasing sales, market share, and…

View Details
Posted 2025-12-22

Lead Sales Supervisor

Coach
Somerville, MA

Coach is seeking a Lead Sales Supervisor in Somerville, MA, to drive sales and lead a team in a luxury fashion environment. This role involves managing store operations, developing sales strategies, a…

View Details
Posted 2026-01-01

Controller

JVS Boston
Boston, MA

Position: Controller Supervises: 3 Staff Reports to: Chief Financial Officer FLSA: Exempt   JVS is a non-profit, non-sectarian agency. Our mission is to empower individuals from diverse c…

View Details
Posted 2025-08-12