Manager, Global Biostatistics & Programming - Remote

Date: Jan 11, 2023

Location: Raleigh, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 7541

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Interventional Urology – NeoTract is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. As part of the Teleflex Interventional Urology business unit, NeoTract’s focus is on improving the standard of care for patients with benign prostatic hyperplasia (BPH) using the UroLift® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function*1,2. The UroLift System is clinically proven to treat lower urinary tract symptoms due to BPH in men over the age of 45. The UroLift System lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue. More than 400,000 men have been treated with the UroLift System in select markets worldwide.** Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. 

 * No instances of new, sustained erectile or ejaculatory dysfunction in the FDA pivotal study.

** Management estimate based on product sales and average units per procedure

  1. Roehrborn, J Urology 2013 LIFT Study
  2. McVary, J Sex Med 2014

Indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge.1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Speak with your doctor to determine if you may be a candidate.

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) collaborative research projects, publication building, PMCF studies and clinical trial development (e.g., sample size calculation & justification). As an integral member of Global Scientific Communications, this position manages a team that is 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 team capable of sustaining biostatistics and programming for Global Teleflex, supporting all business units, 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 high-level in a fast-paced, dynamic environment is essential. 

Principal Responsibilities

• Build collaborations with Global Clinical, Scientific 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, PMCF studies and clinical trial development  
  • Determination and justification of study populations through sample size calculations (with written justifications to be included in protocols and manuscripts) 

•    Further support of Global Clinical Operations may include:

  • Aid ongoing study data quality through closeout and archival, including edits checks per data validation plan or data management plan
  • 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
•    Lead and grow the biostatistics team including employee and team development and support and performance management  
•    Directly responsible for the management of SAS programmers 
•    Write SAS programs for and validates 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

•    Minimum of bachelor’s degree required in a quantitative discipline (e.g., statistics, operations research, bioinformatics, economics, computational biology, computer science, mathematics, physics, electrical engineering, industrial engineering) with at least 5 years of direct biostatistics and programming experience in a pharmaceutical, medical device, clinical or academic research setting  
OR
•    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 3 years of direct biostatistics and programming experience in a pharmaceutical, medical device, clinical or academic research setting required  
•    Minimum of one-year prior experience managing other team members, including making employment decisions and supporting employee and team development
•    SAS Expertise required; certification preferred
 

Specialized Skills / Other Requirements

•    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 time. Overnight and international travel may be required. 
 

 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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