Job Description

Associate Director Biostatistics** Do you want to work in Oncology or in Rare Diseases? Do you want to utilize your exp. in Bayesian modelling? Boston, MA (Hybrid)

Location: Boston, MA - Please note our role is Hybrid part office part home, expected to be in weekly in their the Boston or in Connecticut sites. If you are based outside of Massachusetts, the role comes with a full and comprehensive relocation package.

Our client is a global biopharmaceutical company headquartered in Boston, MA working toward developing accessible treatments for rare diseases and rare cancers. In less than 25 years it has grown to establish itself as a leading light in the treatment of rare diseases.

They have a varied and robust pipeline spread across their core therapeutic areas which includes Oncology and Neurology and they have several successfully marketed products sold globally in all major regions. They are well known in the Boston scientific community for having a collaborative working culture and offering generous packages, including higher-than-average vacation days, yearly vesting stock and decent bonuses.

The company is solid, and stable, with good cash reserves with several high-profile submissions planned for 2024 and 2025. This is an organization moving in the right direction!

Summary

As the Associate Director of Biostatistics, you will be responsible for the design, analysis and interpretation of clinical trials data, ensuring the highest quality standards and regulatory compliance, supporting and work closely with various other functions in clinical development, such as clinical pharmacology, clinical sciences, clinical operations, data management, medical affairs and regulatory affairs.

This position will report directly to the Vice President and Head of Biostatistics and Data Science who has over 2 decades of biotech/pharmaceutical industry experience providing strategic and operational expertise on clinical trial design and execution, statistical analysis, and regulatory strategy and is happy to share his knowledge and be a mentor. There are several different career paths available, including people management and team leadership, and most Biostatisticians here stay and grow with the organization because they know opportunities to face new challenges are readily available.

Your Role!

• Contribute to the design and development of clinical trial protocols, including sample size calculations, randomization, and statistical analysis plans (SAPs).
• Perform and oversee the statistical analysis of clinical trial data, including safety and efficacy endpoints.
• Review and validate outputs including SDTM/ADAM specs and datasets, TLFs, define files and review guides, ensure data integrity, quality, and accuracy.
• Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up.
• Responsible for providing statistical leadership for the preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies.
• Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modelling and simulation, adaptive design and /or Bayesian approaches).
• Work with CROs to support data processing, standardization, transfer and integration.
• Implements automation techniques for timely delivery of safety and efficacy data.

Your Background!

• D. or Masters degree in Statistics/Biostatistics or a related field.
• Substantial experience in biostatistics (7+ years) within the pharmaceutical industry.
• Solid working knowledge and experience in oncology or rare disease clinical trials.
• Familiarity with relevant regulatory guidelines and requirements (FDA, EMA, ICH), experience in regulatory submissions preferable.
• Excellent communication and interpersonal skills.
• Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modelling and adaptive design.
• Knowledge of regulatory requirements relating to clinical development of drugs and biologics.
• BLA/NDA experience including eCTD submissions.
• Working knowledge of major statistical software programs including SAS.
• Knowledge of CDISC requirements for SDTM and ADaM.

To Apply!

Please click the \xe2\x80\x9cApply for position\xe2\x80\x9d red box or get in touch with me, Theo Moore at Theo@AdvTalent.com or call directly at 587.216.9302.

ADV Talent Partners