Associate Director, Biostatistics** Join a growing Biotech with a strong pipeline in Rare Diseases (Onc/Hemo & Neuro) + Opportunities to matrix manage a team** Locations in Bridgeport & Stamford, CT

Reference: 9880

Expiry Date: 31-03-2024

Categories Biotech, Clinical Research, R & D

Salary: Competitive

Job Type: Full Time

Location:
New Haven County
United States

Benefits:

  • Dental
  • Flexible Hours
  • Medical
  • Life Insurance
  • Retirement Plan
  • Sick Days
  • Vacation
  • Vision Insurance

Apply for position

Job Description

Associate Director, Biostatistics** Join a growing Biotech with a strong pipeline in Rare Diseases (Onc/Hemo & Neuro) + Opportunities to matrix manage a team** Locations in Bridgeport & Stamford, CT

Location: Locations in Bridgeport & Stamford, CT - Please note our role is Hybrid so part office part home, expected to be in weekly at their site.

  • Are you a Biostatistics professional, now looking for a challenging and rewarding role?
  • Do you have comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modelling and adaptive design?
  • Would you like to (matrix) manage a team and be accountable for the production of biostatistics deliverables?
  • Do you want to work for an organization committed to the Rare Disease Community with a focus on Oncology, Neurology and Hematology projects?

Position Summary

Our client is a highly successful research-based bio-pharmaceutical company who are leaders in developing and commercializing Rare Disease indications. They have a strong pipeline across all stages of development (including Oncology) and have an established marketed products portfolio. They are financially strong and unlike many other companies at the moment, they are growing and recruiting due to success and organic growth. They are inclusive and collaborative and are continually recognized and rewarded for being one of the best places to work.

The Role:

  • The Associate Director of Biostatistics is a member of cross-functional Development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
  • You will ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents and coordinate the achievement of major statistical deliverables and milestones in collaboration with other functions.
  • You will work collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials and serve as the study level biostatistician including participating in study design and protocol review discussion.

Responsibilities:

  • Provide statistical support to clinical development through the design and conduct of multiple clinical studies through all stages of development across several therapeutic areas including Oncology, Neurology and Metabolism.
  • Participate in cross-functional protocol design and review discussions, and support protocol development to ensure appropriateness of trial design, sample size, and statistical methodologies.
  • Lead development of statistical analysis plan, data presentation plan, DMC charter, and other relevant documents by collaborating with cross-functional partners to meet project timelines.
  • Review the accuracy/consistency of clinical data and statistical outputs, perform ad-hoc statistical analysis, interpret study results, and collaborate with cross-functional partners to produce interim reports, final reports, scientific publications, and internal/external presentations.
  • Collaborate with clinical operations, data management, statistical programing and CRO to develop and implement CRFs, database design, and the overall data quality plan.
  • Review vendor data transfer specifications and ADaM programming specifications
  • Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets.

The experience you bring:

  • PhD (8+ years’ experience ) or MS (10+ years’ experience ) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.
  • Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
  • 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.
  • Great interpersonal, communication, writing and organizational skills.
  • Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework.

To Apply!

Please click the “Apply for position” red box or get in touch with me, Theo Moore at Theo@AdvTalent.com or call directly at 587.216.9302.