Director, Biostatistics

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. In 2023, Lantheus had more than $1B in revenues, led by sales of imaging agents for cardiac ultrasound and for prostate cancer.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of role

We are seeking a highly skilled Director of Biostatistics to join our team. In this role, the 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. The Director 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.

Additionally, the Director will be responsible for developing and implementing biostatistics policies, standards, procedures, and work instructions in alignment with other functions. The individual will also represent the biostatistics function in interactions with Contract Research Organizations (CROs), institutional review boards (IRBs), and regulatory agencies.

Key Responsibilities/Essential Functions

• Develop and implement advanced methodologies based on cutting-edge statistical research, and effectively disseminate results both internally and externally.
• Assist in the design of complex and innovative study methodologies, conduct data analyses, and support the development of specialized software to enhance statistical work.
• Provide expert statistical consultation to Lantheus management across functions in Clinical Development other relevant functions.
• Foster effective collaborations with non-statistical researchers across various research and development areas.
• Stay current with advancements in statistical methodology and apply them to meet Lantheus' evolving business needs.
• Provide technical leadership and statistical expertise to clinical development teams, specifically in the design and execution of oncology clinical studies.
• Contribute to protocol development, ensuring the study design, sample size, and statistical methodologies are appropriate and efficient.
• Lead the creation of statistical analysis plans, data presentation plans, clinical development plans, biometrics-related submission activities, and post-submission strategies/responses.
• Review and verify the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical teams to produce interim and final reports, as well as publications.
• Write and review sections of documents for regulatory submissions and assist with the development and review of other regulatory processes.
• Evaluate vendor data transfer specifications and ADaM programming specifications.
• Lead the introduction of novel statistical methodologies to implement effective solutions.
• Represent the biostatistics function or biometrics department in cross-functional teams, ensuring statistical integrity and collaboration.
• Work with department leadership to develop and implement department policies, standards, and procedures.
• Collaborate with clinical operations, data management, and CROs to develop and implement CRFs, database design, and a comprehensive data quality plan.
• Participate in study team activities as the lead biostatistician.
• 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.
• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risks, and drive project success.
• Participate in regulatory meetings with health authorities to ensure alignment and agreement on project development.

Basic Qualifications

• PhD in Statistics, Biostatistics, or a related discipline with 8+ years of experience, or an MS with 11+ years of experience, specifically in the pharmaceutical/biotech industry, or diagnostic imaging technologies.
• This position is site-based and requires a presence on-site in Bedford, MA three days per week.

Other Requirements

• Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA).
• In-depth knowledge of CDISC standards.
• Good working knowledge of ICH, FDA and GCP regulations and guidelines.
• Technical expertise and knowledge of experimental design and analyses using SAS, R, or Python etc.
• In-depth knowledge of Bayesian statistics.
• Excellent written and verbal communication skills.

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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 talentacquisition@lantheus.com.