Senior Director, Biostatistics

POSITION SUMMARY

Position Title: Senior Director, Biostatistics

Reports to: Vice President, Clinical Development

Status: Regular, Full-time, Exempt

Location: South San Francisco, CA

Summary: The Senior Director, Biostatistics, is responsible for providing statistical leadership and expertise in support of the clinical development programs. The Senior Director will be responsible for establishing and developing broader company strategy and translating into multi-functional objectives. The Senior Director will interact with internal executive level management, 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 Senior 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.

This position is based in our South San Francisco, CA, location, with flexibility to work remote some of the time, and will be required to be on-site for meetings on a routine basis.

Specific responsibilities include, but are not limited to:

• Serving as the statistical lead for clinical development programs, providing strategic and operational expertise for all stages of clinical development programs and support of other functions.
• Providing strategic input into clinical study design, sample size estimation, randomization methods, and statistical analysis planning.
• Overseeing the development and execution of Statistical Analysis Plans (SAPs), tables, listings, and figures (TLFs) for clinical trials.
• Authoring or reviewing statistical part of protocols and Clinical Study Reports (CSRs) and other related documents to ensure scientific integrity of the applied statistical methodology.
• Directing vendors to perform all statistical related tasks
• Partnering closely with Clinical, Regulatory, and Medical Writing to support regulatory submissions, including INDs, NDAs, BLAs, and responses to health authority questions.
• Collaborating with Data Management and Clinical Operations to optimize study execution, data integrity, and statistical efficiency.
• Ensuring accuracy, consistency, and compliance of statistical deliverables with regulatory standards (FDA, EMA, ICH, etc.).
• Interacting with Regulatory agencies at face-to-face meetings or through other forms of correspondence.
• Planning and managing all biostatistical activities.
• Mentoring and managing a team of biostatisticians, fostering professional growth and technical excellence.
• Staying current with new statistical methodologies, regulatory trends, and industry best practices, and proactively implementing improvements.

This job description outlines the primary duties and responsibilities of the role; however, it is not intended to be all-inclusive. The scope of responsibilities may be modified, expanded, or adjusted at the discretion of the organization to meet evolving business needs.

Qualifications Include:

• 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.
• 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.
• Dynamic self-starter; agile learner; strategic and creative thinker
• Proven ability to work under minimal supervision

Pay Range: $281,900 - $298,000 annualized

The stated pay range for this position reflects the San Francisco Bay Area job market. Assembly Bio establishes pay ranges based on geographic work locations. Additional factors such as academic credentials and relevant experience will influence the actual salary offered.

About Assembly Bio

Assembly Bio (NASDAQ: ASMB) is an ambitious biopharmaceutical company with cutting- edge therapeutic clinical candidates capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world, and research and preclinical programs focused on the discovery of novel antivirals to treat devastating viral diseases, including HBV, hepatitis delta virus (HDV) and herpesviruses.

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.