About the role

Biostatistics and Programming-Biostatistician ConsultantBiostatistics and Programming-Biostatistician ConsultantDirect message the job poster from Aequor Our client a clinical stage biotechnology company is seeking a Biostatistician to join their team for a 1-year contract. As the Biostatistician you will participate in developing plans for 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. The Biostatistician will provide technical support for ongoing clinical trials, publications, and other business needs. This position can be remote as long as the person can be available to interact with team during reasonable business hours (e.g.9AM to 3PM EST). Will typically work 30-40 hours per week, will vary based on project/workload. Key responsibilities of this role include, but are not limited to:
  • 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:
  • 10+ years of experience with MS or 7+ year of experience with Ph.D. in clinical drug development. Prior experience working with oncology studies (solid tumor or hematologic malignancies) is highly preferred. Past NDA/BLA submission experience is desirable.
  • Proficiency in statistical programming languages/software such as SAS, R, etc.
  • Extensive knowledge of FDA/ICH guidelines and CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines; In-depth knowledge of the global drug development process.
  • Demonstrated written and oral communication skills and ability to work within a team and work independently are required.
  • Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.
  • Desire to work in a fast-paced, innovative environment
Education
  • MS/Ph.D. in Statistic, Biostatistics, Mathematics or related field
Seniority levelSeniority levelMid-Senior level Employment typeEmployment typeContract Job functionJob functionScience IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Aequor by 2x Get notified about new Biostatistician jobs inNew Haven, CT. Revenue & Coding Analyst - Radiology - (Medical coding experience needed) *AVAILABLE TO WORK REMOTE*Planetree Person-Centered Care Consultant, EuropeDerby, CT $90,000.00-$110,000.00 9 months ago Remote Professional Coding Educator/AuditorRemote Professional Coding Educator/AuditorPlanetree Person-Centered Care Consultant, USADerby, CT $90,000.00-$110,000.00 5 months ago Business Development Manager (USA East Coast, AI) Connecticut, United States $260,000.00-$300,000.00 1 hour ago Connecticut, United States $300,000.00-$360,000.00 1 hour ago Associate Faculty - Business Intelligence and Analytics (online) Director of Business Development - Digital HealthCall Center Specialist - Remote - Part-Time (22.5hrs/wk) - Bilingual REQUIRED (Spanish/English) - $2General Dentists, Endodontists, & Oral Surgeons – Supporting Military Health ReadinessSr. Clinical Research Director, Core Surgical InnovationsDirector of Business Development - Forsyth Health - RemoteWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Matching similar jobs

JOB OVERVIEW

Salary

$90,000 per year

Experience level

Senior

Location

New Haven, CT

Occupation

Biostatisticians

Industry

Other Scientific and Technical Consulting Services

Posted

today

Tired of running searches?

Rank the roles you'd take once, and matches like these arrive on their own.

CREATE PROFILE