Location: South San Francisco, California, United States
The Director will provide statistical leadership and expertise in support of the clinical development activities for Phase I – III global clinical trials. You will be responsible to contribute strategically to project decisions with a focus on pre‐study planning including sample size/power calculations, Statistical Analysis Plan preparation, data quality reviews, development of tables/listings/figures, preparation/mapping of clinical study data for regulatory submission, and integrated safety and efficacy reporting. The Director will also apply innovative statistical approaches to the work (e.g., modeling and simulation, adaptive design/Bayesian statistics), support and defend analyses and their interpretations in internal cross-functional meetings and prepare and communicate responses to agency inquiries.
- Serve as lead statistician on project teams, providing strategic and operational expertise for all stages of cardiovascular clinical development programs and support of other functions
- Write or review protocols, SAP, CSR and other related documents to ensure scientific integrity of the applied statistical methodology
- Direct vendors to perform all statistical related tasks
- Ensure quality review of study documents (IVRS instructions, case report forms, etc.)
- Interact with Regulatory agencies at face-to-face meetings or through correspondence
- Plan and manage all biostatistical activities
- PhD in Statistics or Biostatistics; 10+ years of clinical development experience in the pharmaceutical/biotech industry or MSc in Statistics and 15+ years of experience
- Experience with regulatory interactions (FDA or EMA)
- Solid understanding of clinical trial principles and regulatory requirements
- Knowledge of industry data standards
- Proficiency with statistical analysis software such as SAS and/or R
- Demonstrated ability to work in a team environment. Able to thrive in a small group setting, possesses high energy hands-on attitude.
- Excellent communication skills
- Dynamic self-starter; agile learner; strategic and creative thinker
- Proven ability to work under minimal supervision
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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