Director, Biostatistics

BlueRock Therapeutics; Cambridge (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading company in biopharmaceuticals seeks a Biostatistics representative to provide strategic leadership in clinical development plans and statistical methodologies. The position involves overseeing statistical analysis plans and interacting with regulatory bodies. A PhD in statistics or biostatistics is required along with extensive experience in clinical trials, making this role essential for the success of clinical programs.

Qualifications

• PhD with at least 6 years of experience or Master's with 8 years in clinical trials.
• Experience with NDA/BLA/MAA development.
• Competence in CDISC standards.

Responsibilities

• Contributes to clinical development strategy and design.
• Develops statistical methodologies for clinical trials.
• Provides statistical support and oversight for Data Monitoring Committees.

Skills

Interpersonal skills

Strategic thinking

Communication of statistical concepts

Statistical software (SAS, R)

Understanding of regulatory requirements

Education

PhD in Statistics or Biostatistics

Master’s degree in Statistics or Biostatistics

Job description

This position will provide statistical strategic leadership in one or more therapeutic areas, including contribution to clinical development plans, protocol designs, statistical simulations, and regulatory interactions. Reporting to the Head of Biometrics, this position will also provide guidance to data management and statistical programming in data collection and analysis to support clinical programs within BlueRock, participate in the SOP development as well as oversee the activities of external vendor biostatistics teams to ensure deliverables are met with quality.

Responsibilities:

• Biostatistics representative in the Clinical Strategy Team
• Provides key contributions to the clinical development strategy and plan including but not limited to design options, simulations to evaluate operating characteristics of study designs, and probabilities of Go/No Go decisions
• Develops and implements innovative statistical methodologies such as Bayesian methods and adaptive designs for clinical trials and research studies.
• Provides technical leadership in the design and execution of clinical trials and statistical analysis plans.
• Provides statistical consulting to other functions within development.
• Generates and/or verifies sample size calculations and randomization schedules as needed
• Biostatistics representative in regulatory interactions for assigned programs
• Provides education and training on statistical methods and keeps up to date on the latest developments in statistical methodologies in clinical research
• Writes statistical sections of the clinical trial protocols
• Provides statistical support and oversight of Data Monitoring Committees and Independent Statistical Analysis Centers.
• Contributes to clinical study reports and regulatory documents
• Contributes to the Biometrics SOPs development
• Participates in other activities and meetings to support Biometrics as necessary

Minimum Requirements:

• Excellent interpersonal and influencing skills
• A good team player with excellent strategic thinking skills
• Demonstrated ability to communicate complex statistical concepts to non-statisticians
• Extensive experience with Statistical software (e.g. SAS, R) and CDISC standards Experience working on NDA/BLA/MAA development and submissions. Strong understanding of regulatory requirements and guidelines (e.g. FDA, EMA)
• A PhD degree in statistics or biostatistics with at least 6 years’ experience or a master’s degree in Statistics or Biostatistics with at least 8 years’ experience in clinical trials with a pharmaceutical sponsor.

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