Sr Director, Biometrics

We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. 

Overview

• The Sr Director, Biometrics oversees the entire biometric service offering at Lexitas to include Data Management, Biostatistics, Statistical Programming and Medical Writing . Through this individual’s leadership, all the Biometric functions will collaborate cross-functionally   to support the biometric needs of sponsors. This individual will champion methods and best practices associated with Data Management, Biostatistics, Statistical Programming and medical writing in the planning, execution, summary, and interpretation of clinical projects and studies.

Responsibilities

• Builds and leads a world-class Biometrics department that is seen as a business asset that attracts, develops, and retains top talent in Data Management, Biostatistics, Statistical Programming and Medical Writing.
• Oversees the scope of work, objectives, quality of deliverables, and other biometrics related activities, and ensures client projects are resourced appropriately. 
• Build and support synergies between Clinical Operations, Data Management, Biostatistics, Statistical Programming and Medical Writing functional areas to support the efficient development of high-quality study deliverables.
• Ensures the statistical integrity of protocols, statistical analysis plans, clinical study reports, presentations, and publications of clinical trial data.
• Collaborates with internal and external stakeholders in the design, collection, analysis, reporting, interpretation, and publication of clinical trial data.
• Leads, guides, and manages Biostatistics, Medical Writing and Statistical Programming resources ; including contractors supporting the biometric offering, to ensure high quality and timely deliverables; Develops budgets, sets priorities, and ensures consistency and adherence to standards and departmental SOPs.
• Leads in the development and rollout of new innovations, standards, processes, and programming efficiencies across biometrics.
• Champions the Biometrics department across all areas of Lexitas; Creates excitement and passion for these departments to inform decisions across the organization.
• Maintains a broad understanding of relevant external trends, anticipating relevant emerging issues, identifying strategic needs in technical knowledge, and setting the strategic direction to meet regulatory, scientific, and business needs.
• Works with third party providers to deliver services where required in the support of customer contracts.
• Represents Lexitas in interfaces with Sponsors, vendors, and regulatory agencies.
• Responsible for the provision of scientific and technical consultation both internally and externally to Lexitas.
• Support development of external relationships with academic and industry experts to allow the offering to stay abreast of emerging methodologies; Identifies, selects, and develops partners, including vendors and collaborators, ensuring alignment with Lexitas and Sponsor goals.
• Represents Lexitas at professional societies, external scientific forums, and industry-wide technical discussions through SME provision, as applicable.
• Ensures SMEs within the group stay up-to-date with regard to knowledge of industry and academic developments in biostatistical methodology, regulatory trends, data and programming standards, and ophthalmology.
• Develops others by identifying and mentoring high performers and building a culture of inclusion and collaboration; Delegates responsibility and empowers others; Encourages employees to exercise good judgement and embrace decision making; Empowers capable individuals to be accountable decision-makers.
• Ensures high customer satisfaction across projects for both internal and external customers. 
• Identifies quality issues and collaborates with Quality Assurance to develop and implement appropriate corrective action plans. Escalates findings and action plans to appropriate parties. 
• Provides expertise and consultation through SME provision to project teams and serves as a key point of contact with senior management within the organization to continuously assess and improve operational project delivery. 
• Monitors the qualitative and quantitative progress of biometrics implementation activities; oversees study reporting and tracking of key indicators for evaluation of performance and progress. 
• Ensures consistent use of study tools, training materials, and compliance with standard processes, policies, and procedures. 
• Participates in business development activities including proposal and budget development and evaluates the feasibility of potential programs and their impact on department operations and goals

Requirements

Education: This position requires a BA, BS or advanced degree with at least ten years of experience in biometrics in a CRO setting. At least 5 years experience in a leadership position.

Experience:

• Detailed knowledge of statistical methodologies and statistical regulatory requirements preferred
• Individual must have demonstrated skill in the planning, analysis, and reporting of clinical trials.
• Individual should have t experience with SAS and CDISC standards.
• Experience with one or more electronic data capture systems. 
• Experience in ophthalmology preferred. 

Skills:

• Comprehensive understanding of statistical, programming, and data issues in clinical trials.
• Experience leading and conducting all biostatistical aspects for clinical trials and serving as a core technical resource to others.
• Sound knowledge of all relevant regulations and guidelines.
• Excellent verbal and written communication skills. Excellent presentation skills.
• Experience leading and conducting data management activities for clinical trials and serving as a core technical resource to others. 
• A successful history of cross-functional collaboration. 
• Good planning and organizational skills with the ability to adapt and adjust to changing priorities. 
• Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment. 
• A strong interest in developing expertise in ophthalmology. 

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.