drjobs Senior Staff Biostatistician (Remote)

Senior Staff Biostatistician (Remote)

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1 Vacancy
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Job Location drjobs

Indianapolis, IN - USA

Monthly Salary drjobs

$ 100500 - 215300

Vacancy

1 Vacancy

Job Description

Work Flexibility: Remote

Stryker Neurovascular is seeking a Senior Staff Biostatistician to lead statistical strategy and execution for clinical trials supporting innovative neurointerventional medical devices. In this role you will play a critical part in shaping clinical evidence ensuring regulatory readiness and advancing patient care through datadriven insights. This is a remote position to be located anywhere within the United States preferably on the Central or Eastern time zone.

What you will do

  • Lead statistical planning and analysis for clinical trials including development of statistical analysis plans (SAPs) and interpretation of complex data

  • Design and validate SAS programs to generate clinical datasets tables listings and figures (TLGs) in compliance with regulatory standards

  • Collaborate with crossfunctional teamsincluding clinical scientists regulatory affairs and neurointerventional physiciansto optimize study design and endpoints

  • Provide statistical input for regulatory submissions (e.g. FDA EU MDR) and support clinical study reports (CSRs)

  • Contribute to scientific publications and conference presentations to communicate clinical evidence

  • Ensure statistical best practices across projects

  • Stay current with evolving regulatory guidance and statistical methodologies relevant to medical devices

What you need

  • Bachelors degree in Biostatistics Engineering Science or related field

  • 6 years of experience in clinical biostatistics

  • Proficiency in SAS programming; strong ability to communicate statistical concepts to nonstatisticians.

  • Experience with clinical trial data analysis inferential statistics and regulatory documentation.

Preferred

  • MS or PhD in Statistics Mathematics or related field

  • 4 years in medical device pharmaceutical or biotech settings

  • Experience with SQL SAS Macros and electronic data capture (EDC) systems

  • Experience in R programming

  • Prior contributions to peerreviewed publications or scientific presentations

  • Familiarity with ISO 14155 FDA guidance and EU MDR requirements

$100500.00 $215300.00 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors.

Travel Percentage: 0%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.


Required Experience:

Staff IC

Employment Type

Full-Time

Company Industry

About Company

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