Sr. Manager Biostatistics

1 month ago

Secaucus, United States Frontage Laboratories Full time
Job DescriptionJob Description

Sr. Manager Biostatistics

Position: Sr. Manager, Biostatistics

Reports to: VP, Clinical Services

Location: Remote

Full-time

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Duties: Supervise statistical programmers in implementation and execution of methodological and statistical aspects of clinical studies. Manage biostatistical activities related to drug product development for assigned clinical studies. Collaborate with study teams internally and with clients, manage study timelines, and ensure the quality of the statistical analysis output.

Supervises: Statistical programmers, biostatisticians

Qualifications: MS or PhD in Statistics or Biostatistics. Excellent communication and writing skills, good programming skills in SAS, S-plus or other statistical software, and ability to work in a team environment. Experience managing staff and statistical programming. Knowledge of concepts and methodologies of QA. Knowledge of relevant regulatory requirements.

Experience: 5+ years (for MS) or 3+ years (for PhD) of experience in clinical trials for regulatory submission in the pharmaceutical, biotech, or CRO environments.

Specific Responsibilities:

  • Provide statistical expertise in clinical trials and collaborate with Clinical Research and Medical Writing groups on clinical trial protocols, case report forms, statistical analysis plans and other study related documents.
  • Write or provide guidance to study statisticians and biostatistical programmers for development of a Statistical Analysis Plan, statistical analysis and derived analysis datasets.
  • Ensure the accuracy and quality of the statistical analysis output.
  • Manage study resources and timelines.
  • Have in-depth knowledge of FDA and ICH guidelines and regulations and industry data standards, e.g., CDISC, SDTM and ADaM.
  • Develop, revise and/or review SOPs relating to biostatistical services.
  • May provide statistical expertise and advice for submission of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.


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