View Our Website View All Jobs

Manager, Biostatistics

MMS Holdings Inc. is a global pharmaceutical service organization (CRO), that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. We are a pharmaceutical service provider supporting pharmaceutical and biotech industries with medical writing, biostatistics, clinical programming, data management, clinical development, regulatory affairs, regulatory submissions and pharmacovigilance.

Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients' lives worldwide.

Roles & Responsibilities

  • Provides leadership, mentors, and develops personnel by maintaining a positive work environment
  • Directs, manages and oversees the daily activities of personnel
  • Confidently displays excellent internal and external customer service
  • Responsible for implementation and execution of high quality statistical analyses
  • Provides high level of support to the programmers and medical writers on all statistical matters according to client requirements
  • Provides advanced input into statistical sections of the protocol, amendments, and Clinical Development Plan per client requirements
  • Develops statistical analysis plans (SAP) and assists in preparing the data validation plan per client requirements
  • Works with programming team to provide definitions, documentation, and review of derived variables needed to produce planned tables, listings, and graphs (TLGs)
  • Provides guidance for data and programming specifications jointly with programmers
  • Performs, coordinates, and oversees analysis according to the SAP, validates analysis programs, reviews TLGs, prepares statistical methods and results sections for the clinical study report (CSR)
  • Assists in writing efficacy sections of clinical study reports and summary documents with in-house medical writers and the client’s study team
  • Responsible for planning and on-time delivery of project deliverables that meet quality objectives
  • Leads projects, delegates tasks, and manages timelines, resources, budgets, clients, internal team, and deliverables independent of management

Requirements

  • College graduate in statistical discipline, computer science or related field, or related experience
  • Expertise in drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality analyses
  • Hands-on experience with clinical trial and pharmaceutical development
  • Experience with data and production of TLGs
  • Programming and logic skills
  • Experience in pharmaceutical or CRO industry
  • Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques
  • Scientific writing skills
  • Excellent organizational and communication skills
Read More

Apply for this position

Required*
Apply with Indeed
Attach resume as .pdf, .doc, or .docx (limit 2MB) or Paste resume

Paste your resume here or Attach resume file

150