Executive Director Biostatistics

Lantheus; Massachusetts; On-site; USD 206,000 - 381,000; Full time

Benefits offered by this job

Health benefits

401(k) with company contribution

Paid time off

Job summary

Lantheus, a leading radiopharmaceutical company headquartered in Massachusetts, seeks an Executive Director of Biostatistics to lead clinical development statistics for all phases. This role is based in Bedford, MA with on-site presence two to three days per week and requires collaboration across Clinical Development, Regulatory, and cross-functional teams.

The candidate will design statistical strategies, author regulatory documents, and ensure high-quality data interpretation for submissions.

Qualifications

• PhD in Biostatistics or a related field.
• Typically, 20+ years in the pharmaceutical industry or CRO with at least 10 years in a management position.
• Prior experience as a lead Biostatistician in clinical development.
• Prior experience managing clinical teams to design and implement studies.
• Experience in writing statistical sections of protocols and CSRs.
• Experience with CRFs and programming specifications.
• Excellent communication skills and technical writing experience.

Responsibilities

• Provide expert statistical consultation to Lantheus management across Clinical Development and Asset Teams.
• Lead the Biostatistics team and direct and execute statistical strategy for development programs.
• Evaluate and manage CROs and vendors, overseeing scope, timelines, and study activities.
• Lead the process and review of in-house and external programming deliverables.
• Stay current with advancements in statistical methodology and apply them to meet evolving needs.
• Contribute to protocol development, study design, sample size, and statistical methods.
• Contribute to study activities, CRF development, database design, and data cleaning.
• Write/review Statistical Analysis Plans for studies and regulatory submissions.
• Work with leadership to develop department policies, standards, and procedures.
• Ensure final deliverables meet CDISC standards for regulatory submissions.

Education

PhD in Biostatistics

Tools

SAS software

Job description

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years.

Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world.

At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress.

Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands.

Summary Of Role

The Executive Director, Biostatistics leads the activities of the biostatistics and statistical functions within the Clinical Development department. The incumbent is responsible for the execution of clinical trials and regulatory submissions with respect to clinical data for all phases of development.

The Executive Director will serve as the project-level biostatistician, providing expertise in the development and execution of statistical strategies, study designs, statistical analyses, and regulatory submissions for clinical development across various therapeutic areas. He/she will collaborate closely with clinical science, regulatory, and other cross-functional teams to develop clinical development plans, author key clinical, regulatory, and statistical documents, and ensure the high-quality delivery and interpretation of clinical data. These responsibilities include resource allocation and implementation as well as strategic planning.

The Executive Director will also be responsible for assigning workload and managing direct reports.

This position is based in Bedford, MA and requires a presence on-site of (two/three) days per week. It is open to applicants authorized to work for any employer within the United States.

Responsibilities

• Provide expert statistical consultation to Lantheus management across functions in Clinical Development other relevant functions, including Asset Teams.
• Lead the Biostatistics team and direct and execute statistical strategy for development programs.
• Evaluate and manage CROs and other vendors, overseeing scope-of-work, timelines, and study activities related to biostatistics and statistical programming, and preparation of deliverables to ensure project success.
• Lead the process and review of in-house and external programming deliverables.
• Stay current with advancements in statistical methodology and apply them to meet Lantheus’ evolving business needs.
• Contribute to protocol development, ensuring the study design, sample size, and statistical methodologies are appropriate and efficient.
• Contribute to study activities, to develop and implement CRFs, database design, and data cleaning activities.
• Write and/or review Statistical Analysis Plans for clinical studies and integrated analyses for regulatory submissions.
• Work with department leadership to develop and implement department policies, standards, and procedures.
• Assure that final deliverables for regulatory submissions meet the requisite standards, including the current CDISC standards for data submission.
• Write and/or review statistical sections of NDAs, INDs and other regulatory submissions as appropriate.
• Prepare for and present at expert meetings and meetings with regulatory authorities.
• Contribute to and review presentations, publications and abstracts.
• Mentor staff as needed.
• Program statistical analyses that require a statistician’s expertise as required.

Basic Qualifications

• PhD or equivalent in Biostatistics or a related field.
• Typically, 20+ years of experience in the pharmaceutical industry or CRO with at least 10 years in a management position.
• Prior experience as a lead Biostatistician in clinical development.
• Prior experience managing clinical teams to design and implement studies.
• Experience in writing statistical sections of protocols, including defining relevant endpoints and performing sample size calculations.
• Experience writing statistical analysis plans and creating summary outputs for clinical study reports.
• Experience with development of case report forms and programming specifications.
• SAS analysis programming skills.
• Experience with statistical software and graphics packages.
• Excellent communication skills and technical writing experience.

Preferred Qualifications

• Previous experience with Diagnostic studies, particularly diagnostic imaging studies, e.g. PET.

The Ideal Candidate Will Embody Lantheus Core Values

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone’s health is in our hands
• Own the solution and make it happen

The pay range for this position is between $206,000 and $381,000 annually.

Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive.

• Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
• Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave.

Applications for this position will be accepted until August 5, 2026.

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at [e-mail].

Lantheus is an E-Verify Employer.

Applicants have rights under Federal Employment Law: Employee Polygraph Protection Act (EPPA); Family and Medical Leave Act (FMLA)

For California Applicants: Family Care & Medical Leave & Pregnancy Disability Leave; California Law Prohibits Workplace Discrimination & Harassment; Your Rights and Obligations as a Pregnancy Employee

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