Biostatistics and Programming-Biostatistician Consultant

Aequor; New Haven (CT); Remote; USD 100,000 - 140,000; Full time

Job summary

A leading clinical stage biotechnology company is seeking a Biostatistician Consultant for a 1-year contract. The role involves providing statistical expertise for clinical trials, collaborating with cross-functional teams, and contributing to regulatory submissions. Candidates should have extensive experience in clinical drug development, especially in oncology, and proficiency in statistical programming. This position can be remote with flexible hours, requiring 30-40 hours of work per week.

Qualifications

• 10+ years of experience in clinical drug development or 7+ years with Ph.D.
• Experience in oncology studies preferred.
• Knowledge of FDA/ICH guidelines and CDISC standards.

Responsibilities

• Provide statistical expertise for clinical development plans and protocol development.
• Collaborate cross-functionally to implement statistical analyses.
• Identify innovative statistical methods to streamline clinical processes.

Skills

Statistical programming

Data analytics

Collaboration

Analytic thinking

Education

MS/Ph.D. in Statistics, Biostatistics, Mathematics or related field

Tools

SAS

R

Job description

Biostatistics and Programming-Biostatistician Consultant

Biostatistics and Programming-Biostatistician Consultant

Direct 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 level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Pharmaceutical Manufacturing

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