Sr. Director, Biostatistics

Lantheus Brand • Bedford, MA

2d • $204,000 - $339,000 • Hybrid

About The Position

The Senior 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 Senior 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 Senior 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.

Requirements

• PhD or equivalent in Biostatistics or a related field.
• Minimum of 12 years of experience in the pharmaceutical industry or CRO with at least 8 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.

Nice To Haves

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

Responsibilities

• Provide expert statistical consultation to Lantheus management across functions in Clinical Development other relevant functions, including Asset Teams.
• 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.
• Leading 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.
• Writing and/or reviewing 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.
• Writing and/or reviewing statistical sections of NDAs, INDs and other regulatory submissions as appropriate.
• Preparing for and presenting at expert meetings and meetings with regulatory authorities.
• Contributing to and reviewing presentations, publications and abstracts.
• Mentoring staff as needed.
• Programming statistical analyses that require a statistician’s expertise as required.

Benefits

• Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree