Director, Biostatistics

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🔥 8 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $199.3k - $272k / year

⏰ Full Time

🔴 Lead

👔 Director

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Neurocrine Biosciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science.

📋 Description

• Develops strategic and operating plans for area of responsibility. • Serves as the overall statistical lead on multiple clinical programs. • Provides statistical input in design, analysis, and reporting of clinical studies. • Interacts with key opinion leaders on protocol design. • Oversees and directs the biostatistics team. • Manages in-house and contract biostatisticians to support analysis and reporting of clinical study data. • Prepares, reviews, and approves statistical analysis plans. • Oversees and monitors CRO performance of statistical analyses and programming. • Provides biostatistical support to nonclinical, medical affairs, and commercial areas as needed. • Leads the development of department standard operating procedures. • Reviews, approves and implements innovative statistical methods.

🎯 Requirements

• Master’s degree in statistics, biostatistics or related discipline AND 10+ years of experience with Phase 1 through Phase 4 clinical studies. • PhD in statistics, biostatistics or related discipline AND 7+ years of similar experience noted above. • Extensive previous leadership experience required. • Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively. • Excellent leadership, coaching and development skills. • Strong negotiation and influencing skills. • Excellent communication, problem-solving, analytical thinking skills. • Advanced knowledge of SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses. • Solid knowledge of working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets. • Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies.

🏖️ Benefits

• Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. • Paid vacation, holiday and personal days. • Paid caregiver/parental and medical leave. • Retirement savings plan (with company match). • Eligibility to participate in our equity based long term incentive program. • Annual bonus with a target of 35% of the earned base salary.