Associate Director, Biostatistics

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Biostatistics based in the United States.

This is a high-impact biostatistics leadership opportunity supporting the development of innovative oncology therapies. You will serve as a lead biostatistician across clinical programs, shaping study design, statistical strategy, analysis, and interpretation throughout the development lifecycle. Working within a highly regulated, multidisciplinary environment, you will partner with clinical, data, programming, regulatory, and other functional experts. Your expertise will help translate complex clinical data into reliable insights that support development decisions and regulatory submissions. You will own key statistical deliverables while providing strategic guidance on trial methodology, data quality, and analytical challenges. The role also offers an opportunity to explore AI-enabled approaches that improve statistical workflows, quality control, productivity, and decision-making. This remote U.S. position is suited to an experienced biostatistician who combines technical depth with strong communication, influence, and leadership skills.

Accountabilities:: Serve as the lead biostatistician for clinical oncology programs, developing and executing statistical strategies, study designs, analyses, and interpretations.

Partner closely with multidisciplinary clinical development teams to establish objectives, align statistical approaches, and communicate analytical considerations throughout the trial lifecycle.

Identify and resolve statistical and data-analysis challenges associated with clinical trials, development activities, and regulatory submissions.

Author and own key statistical documents and deliverables, including statistical sections of protocols, Statistical Analysis Plans (SAPs), and Tables, Listings, and Figures (TLF) shells.

Review study documentation and oversee the quality, accuracy, compliance, and timeliness of external vendor biometrics deliverables, including CDISC specifications and statistical outputs.

Collaborate with statistical programmers to support regulatory requests, DSUR and Investigator's Brochure updates, ad-hoc analyses, and other development needs.

Participate in internal reviews of ongoing clinical data and provide expert statistical interpretation to inform program decisions.

Ensure statistical activities adhere to applicable GCP, ICH, regulatory, organizational, and standard operating procedure requirements.

Explore and pilot AI-enabled initiatives that can strengthen quality control, improve operational efficiency, and enhance team decision-making.

Contribute statistical expertise to global regulatory submission activities and other strategic development initiatives as needed.

Travel approximately 10% of the time and remain available for occasional evening or weekend work based on program needs.

Requirements:

Advanced degree in Statistics, Biostatistics, or a closely related quantitative discipline; PhD or MS required.

At least 6 years of biostatistics experience with a PhD or 8 years with an MS, preferably within the pharmaceutical or biotechnology industry.

Demonstrated experience serving as a lead biostatistician on clinical development programs and providing strategic statistical guidance.

Strong knowledge of statistical methodologies and clinical trial design, with the ability to translate complex analytical findings into practical development recommendations.

Familiarity with statistical programming environments such as SAS and/or R, along with working knowledge of CDISC standards including SDTM and ADaM.

Ability to review, interpret, and challenge statistical programming outputs and other clinical data deliverables.

Demonstrated experience managing or overseeing external vendors and ensuring biometrics deliverables meet quality, timeline, and compliance expectations.

Solid understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.

Excellent interpersonal, written, and verbal communication skills, with the ability to influence cross-functional stakeholders and collaborate effectively across disciplines.

Experience working successfully in highly regulated environments with strong attention to established procedures, documentation, and quality standards.

Demonstrated experience using AI-enabled tools to improve productivity, analytical workflows, or team execution.

Prior experience in oncology clinical development is strongly preferred.

Experience supporting global regulatory submissions is preferred.

Ability to work independently while effectively managing competing priorities and complex projects.

Benefits:

Competitive salary range of $189,670–$229,834 USD for the remote U.S. position.

Potential eligibility for additional incentive cash and stock opportunities, depending on role and eligibility.

Medical, pharmacy, dental, and vision coverage.

401(k) retirement plan and financial well-being resources.

Short- and long-term disability, life, accident, and supplemental health insurance.

Employee assistance and well-being programs.

Flexible paid time-off options, depending on employee classification and eligibility.

Paid national holidays and potential additional paid sick, volunteer, parental, caregiver, bereavement, medical, personal, and military leave.

Annual company-wide shutdown period between Christmas and New Year's Day for eligible employees.

Potential summer-hours flexibility for eligible U.S. employees.

Opportunities for professional growth within a collaborative, multidisciplinary life sciences environment.

Remote work arrangement within the United States.

Workplace accommodations and support for qualified individuals with disabilities.

Opportunity to contribute to the development of innovative therapies addressing serious diseases and unmet patient needs.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1