Title: Associate Director, Biostatistics, Nonclinical
Company: Pharmaceutical Company
Location: Cambridge, MA
Type: Permanent Role
Notes: No Corp to Corp
•Collaborate with preclinical scientists across research units (Immunology & Inflammation, Internal Medicine, Rare Disease, CTI) to design, analyze and present experiments.
• Bring innovative statistical thinking and methods to help drive the enhanced quantitativedrug discovery and development paradigm.
• Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and assay methods are appropriately blinded, randomized and designed to meet clear objectives.
•Serve as a core member of scientific teams responsible for determining strategy and delivering results in a timely and high quality manner.
•Work with scientists to understand the biology and improve existing biomarkers, endpoints, derive new endpoints, and develop 'fit-for-purpose' statistical models.
•Use statistical expertise to prepare both internal and external reports, presentations and manuscripts, with the aim to improve the quality of internal decision making and increase our influence on the external environment.
•Where possible, standardize processes and methodologies within and possibly across therapeutic areas may include developing statistical tools to aid scientists in standardize analyses.
•Provide statistical expertise on regulatory submissions and ensure quality of deliverables.
• PhD in Statistics/Biostatistics and at least 3-5 years of pharmaceutical experience or a MS in Statistics/Biostatistics and at least 5-8 years of pharmaceutical experience
• Strong pre-clinical and non-clinical experience is required
• Must have strong technical competence.
• Capability to provide statistical leadership to cross-functional teams.
• Sound understanding of design of experiments, assay development, and statistical applications for preclinical research
• Interest in biology, graduate level training preferred.
• Good knowledge of drug development regulations pertinent to statistical analysis
• Preferred candidates will have good computational skills in SAS, R, or S-Plus.
• Strong communication skills and the ability to work collaboratively with research scientists are essential.
• Demonstrated ability to work effectively as a part of a team.