Manager Global Biostatistics and Programming (REMOTE)

Position Summary

The Manager, Global Biostatistics and Programming, is responsible for developing and implementing statistical analysis plans (SAPs) as well as producing the key clinical data outputs that align with the evidence generation needs across the organization. The role will be heavily relied upon to provide strategic input during (but not limited to) controlled clinical trial and real-world study protocol development and publication planning and execution (e.g., sample size calculation & justification). As an integral member of the Medical Affairs team, this position manages work and consultants who are directly responsible for biostatistics input, support, and guidance; as well as strategic analysis and programming activities that serve as a critical foundation for publications, presentations, clinical protocols, clinical evaluation reports (CERs), and SAPs (to name a few). During clinical trial execution, the function may be asked to perform interim analyses and monitor the quality of data management deliverables. The Manager will be asked to cultivate a plan for sustaining biostatistics and programming for the Interventional Urology business unit, and will manage external contractors/consultants, ensuring timelines are met according to objectives and goals and/or data reporting needs. Experience managing multiple projects, prioritizing work in line with project management decisions, and the ability to perform at a high level in a fast-paced, dynamic environment are essential.

Principal Responsibilities

•    Customer Experience – Representing Teleflex in a customer-facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and relationship with our customers.
•    Continuous Improvement - Demonstrates initiative and critical thinking to identify, prioritize process and performance gaps. Develops solutions to deliver improved results. Exemplifies continuous improvement, thought processes, and focus.
•    Culture and Values – Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment.
•    Build collaborations with Clinical and Medical Affairs teams to align biostatistical analysis with global evidence generation plans, including but not limited to the following:
•    Long-term evidence generation plans that yield appropriate datasets from which to make evidence-based recommendations  
•    Development and execution of SAPs and statistical analysis reports (SARs)
•    Programming of clinical data outputs for (but not limited to) publications, presentations, and CERs 
•    Strategic input for collaborative research projects, clinical trial development, and real-world study data.
•    Determination and justification of study populations through sample size calculations (with written justifications to be included in protocols and manuscripts) 
•    Further support of Clinical studies may include:
o    Aid ongoing study data quality through closeout and archival, including edit checks per data validation plan or data management plan
o    Review CRF annotations and data specifications and ensure CRFs meet the guidelines of the protocol

•    Manage and coordinate all independent statistical contractors/consultants on multiple projects and timelines; ensure external requests are funneled through this function and prioritized accordingly
•    Write SAS programs to validate tables, listings, and figures, and analysis datasets
•    Utilize SAS programming skills to perform all programming required for clinical trial analysis and reporting 
•    Ensure adherence and consistency per standard operating protocols
•    Produce ad hoc statistical outputs and reports for Clinical, Scientific, and/or Medical affairs teams 
•    Perform other duties as requested
•    Contribute to the Company culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun

Education / Experience Requirements

·    Master’s degree in a quantitative discipline (e.g., statistics, operations research, bioinformatics, economics, computational biology, computer science, mathematics, physics, electrical engineering, industrial engineering) with at least 10 years of direct biostatistics and programming experience in a pharmaceutical, medical device, clinical, or academic research setting required
·    Minimum of 3 years working on projects, including Urology therapies 
·    Minimum of one year of prior experience managing/leading other team members or consultants
·    SAS Expertise required; certification preferred
·    Strong knowledge of US and international clinical regulations and guidance    
·    Strong computer skills in Microsoft Office; high proficiency using electronic data capture systems and off-the-shelf data software
·    Ability to prioritize analytical deliverables through stakeholder management and negotiate timelines as needed 
·    Ability to make independent decisions and take ownership within a fast-moving environment
·    Excellent organizational skills and attention to detail
·    Excellent verbal and written communication skills, including presentation skills
·    Ability to collaborate effectively and participate in a team environment
·    Ability to travel up to 5-10% of the time. Overnight and international travel may be required.

Specialized Skills / Other Requirements

•    Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which NeoTract complies.
•    Sound clinical decision-making
•    Adaptable and welcoming of change, and willingness to explore and implement process improvements
•    Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. 
•    Experience in project management to drive initiatives forward successfully
•    Experience in clinical process improvement is a strong plus
•    Advanced organizational and time management skills
•    Experience in leading by influence
•    Skills in complex analytic problem solving 
•    Ability to recognize potential obstacles and work to resolve them within set timelines
•    Must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
•    Ability to read, understand, and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions, and report on findings.

TRAVEL REQUIRED: 10%

The pay range for this position at commencement of employment is expected to be between $132,900 – $199,400; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in a 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability, and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, the employee will be in an “at-will position,” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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