Sr. Statistical Programmer

Date: Jun 21, 2022

Location: Remote, CA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6306

 

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 175,000 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

#LI-DNI

The Senior Statistical Programmer supports study functions including partnering with Data management, Study Managers and Medical to generate and QC outputs; and ensure timely and accurate programming and validation activities for clinical studies and publications. Review abstract/manuscripts to ensure accuracy, quality and soundness of statistical methodologies This position requires knowledge of clinical trials, understanding of various study designs for data analyses of multiple studies, and the ability to perform at high levels in a fast-paced, dynamic environment.

Principal Responsibilities

•    Write SAS programs to generate tables, listings, and figures and analysis datasets.
•    Providing statistical programming and validation for clinical study reports, final/interim analyses, meetings, other types of analyses, and reports throughout the project.
•    Develop SAS programming codes to independently validate statistical output reports of trial data generated by other programmers or statisticians.
•    Identify and edit checks per the data validation plan or data management plan.
•    Perform quality control on final reports.
•    Support ongoing study data quality, closeout, and archiving high volume data.
•    Collaborate with Data Management and Clinical Affairs team members as needed.
•    Develop and/or review statistical analysis plans, including Table/listing/figure shells, and final study report for clinical studies; perform post-hoc statistical analyses as needed. Work closely with clinicians, and publication managers to generate and QC outputs for publications; review publication (abstract/manuscripts) to ensure accuracy, quality and soundness of statistical methodologies.
•    Providing input to the Database and CRF Development, creating edit check programs and providing feedback to the Data Management. Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.
•    Perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and may work on submission teams as a statistician and/or a programmer.
•    Document data and programming information in accordance with corporate SOPs and guidelines.
•    Work on multiple tasks at the same time and prioritize tasks to meet business needs.
•    Work independently to accomplish tasks and goals defined by supervisor and bringing in new ideas to improve the programming process and maintaining standards for programming activities.
•    Perform other duties as requested.
•    Contribute to the Company culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun!
 

Education / Experience Requirements

•    MS in Biostatistics/Statistics preferred, with at least 6 years of experience in the pharmaceutical, Medical Device or biotech industry experience
•    Strong SAS programming skills, with experience in SAS-Base, MACRO, STAT, and GRAPH.

Specialized Skills / Other Requirements

•    Knowledge of US clinical regulations and guidance preferred.    
•    Applies good judgment and demonstrates initiative to resolve issues.
•    Strong organizational skills with ability to effectively manage multiple projects.
•    Ability to make independent decisions and take responsibility for own actions within a fast-moving environment
•    Ability to travel, up to 5%. Overnight travel is required. 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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