Location: South San Francisco, California, United States
The Director, Biostatistics will provide statistical leadership and expertise in support of the clinical development activities for Phase I – II 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, support and defend analyses and their interpretations in internal cross-functional meetings and prepare and communicate responses to agency inquiries.
Key Responsibilities include:
- Serve as lead statistician on project teams, providing strategic and operational expertise for all stages of 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
Not sure if you are qualified for this position? We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants. You are encouraged to apply even if you do not meet each of the listed preferred qualifications.
Preferred Qualifications include:
- Typical experience for a Director usually includes a PhD with around 10 years of industry experience. Non-PhD candidates with additional years of industry experience are encouraged to apply. Candidates with a strong background in infectious disease will be considered uniquely qualified for this role.
- Demonstrated leadership and interpersonal skills that have enabled you to successfully hire, develop, and retain employees. This includes aligning employees around a common vision and goals, and utilizing complementary strengths and experience to create high-performing teams
- A collaborative and flexible leadership style that allows you to adapt to the nuances of managing a diverse team and the on-going training, coaching, and performance management that results in increased engagement and retention
- 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
- This position is based at our South San Francisco, CA location and the preference is for local candidates who can be onsite 2-3 days per week once it is safe to return to the office. Remote candidates will also be considered.
As a condition of employment, you will be required to show proof that you are fully vaccinated by your first day of employment. You are considered fully vaccinated two weeks after your second dose in a 2-dose series, (Pfizer or Moderna vaccines), or two weeks after a single-dose vaccine, (Johnson & Johnson’s/Janssen vaccine). If you are unable to be vaccinated for a medical or disability-related reason, or a deeply held religious belief, Human Resources will discuss potential exemptions and accommodations with you.
About Assembly Bio
Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio’s approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio’s strategy includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies for HBV cure and research programs focused on the discovery of additional novel antiviral mechanisms for HBV, and other viral diseases. For more information, visit assemblybio.com.
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 set our sights high—and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.
As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind. 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.
Information for Recruitment Agencies
Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.
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