Biostatistician Consultant (Biostatistics & Programming) Job at Tandym Group, New Haven, CT

dGNUaWZSYmZHYWhXU0RPRUhRbGhhS3ArZ3c9PQ==
  • Tandym Group
  • New Haven, CT

Job Description

A Connecticut-based pharma company is actively seeking a new remote Biostatistician to join their growing team. In this role, the Biostatistician will be responsible for participating in developing plans for client's clinical developments by using expertise in statistics, design and analysis of clinical trials, and data analytics and mining through cross-functional collaboration and decision-making process.

Responsibilities:

  • Provide statistical expertise into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives
  • Collaborate effectively cross-functionally (e.g., with clinical research, regulatory strategy, data management, statistical programming, medical writing, etc.) to facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, and serve as internal statistical expert in the overall program
  • Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making

Qualifications:

  • 7+ years of related experience in Clinical Development
  • Master's Degree and/or Ph.D. in Biostatistics, Mathematics, Statistics, and/or a related field
  • Proficiency in Statistical Programming languages/software such as SAS, R, etc.
  • Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides and 21 CFR Part 11
  • Familiarity with EMA/CHMP regulations and guidelines
  • In-depth knowledge of the Global Drug Development process
  • Solid analytical and problem-solving skills

Desired Skills:

  • Prior experience working with Oncology studies (solid Tumor or Hematologic malignancies)
  • NDA/BLA submission experience

Job Tags

Remote job,

Similar Jobs

ACL Digital

Manufacturing Engineer Job at ACL Digital

 ...Role: Manufacturing Engineer Location: Everett, WA / Renton, WA Type: Contract Duration: Long Term Position responsibilities...  ...to read and interpret old 2D drawings ~ Familiarity with aerospace parts/products ~ Proficient in computer skills including Microsoft... 

Colorado High School Charter

HIGH SCHOOL SPECIAL EDUCATION COORDINATOR Job at Colorado High School Charter

 ...Special Education Coordinator Colorado High School Charter is seeking a Special Education Coordinator. The Special Education Coordinator at Colorado High School Charter GES is responsible for overseeing the implementation of special education services for students with... 

TEKsystems

Remote Inpatient Coder - Remote MUST HAVE 3 Years' Experience - CCS (Certified Coding Specialist) Or RHIT/RHIA With Inpatient Coding Job at TEKsystems

 ...and compliance.QualificationsRequired:+ High school diploma or equivalent.+ Certification: CCS (Certified Coding Specialist) or RHIT/RHIA with inpatient coding experience.+ Minimum of 3 years' experience in inpatient coding in an acute care hospital setting.+ Strong... 

Insight Global

Landscape Architect Job at Insight Global

 ...Insight Gloabl is seeking a Landscape Architect for a client in College Park, MD. This role will be responsible for developing site analysis documents, site design studies, site plan review, and alternatives for a wide range of projects related to the overall campus short... 

Asakura Robinson

Landscape Designer Job at Asakura Robinson

 ...Asakura Robinson is seeking to fill a full-time entry-level landscape designer position with a focus on community-based design projects and public facing projects. The successful applicant will demonstrate a strong design acumen and collaborative spirit, proficiency in...