Senior Principal Statistical Programmer

2 months ago

Boise, Idaho, United States Edwards Lifesciences Full time
About the Role

We are seeking a highly skilled Senior Principal Statistical Programmer to join our Clinical Affairs team at Edwards Lifesciences. As a key member of our team, you will play a critical role in driving the evidence needed to optimize patient outcomes.

Key Responsibilities
  • Develop, test, validate, document, maintain, and execute programs in SAS, serving as a lead programmer and taking primary responsibility for reviewing and validating SAS programs created by junior-level programmers.
  • Provide programming expertise on multiple clinical trials, including programming, documentation, validation, and review of summary tables, data listings, and graphs for inclusion in clinical reports or presentations in collaboration with project statisticians.
  • Lead in programming analysis datasets in multiple clinical trials and provide programming expertise on complex ad hoc data requests in collaboration with project statisticians.
  • Lead a team of programmers in the development of program specifications and design documents in partnership with project statisticians.
  • Collaborate with management to develop or improve procedures and standards.
  • Lead a team of programmers in collaboration with cross-functional teams to ensure that database and external data sources meet analysis requirements across clinical trials.
  • Ensure that analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review.
Requirements
  • Bachelor's Degree in Statistics, Mathematics, or Computer Science with 8 years of previous experience in Statistical Analysis.
  • Masters Degree or equivalent in Statistics, Mathematics, or Computer Science with 7 years of previous experience required.
  • PHD or equivalent in Statistics, Mathematics, or Computer Science with 4 years of previous experience required.
  • Proven expertise in MS Office Suite, including Word, PowerPoint, Access, and Excel.
  • Excellent written and verbal communication skills and interpersonal relationship skills, including negotiating and relationship management skills with the ability to drive achievement of objectives.
  • Keeps abreast of new developments in statistics and regulatory guidance.
  • Expert understanding and knowledge relevant to statistical programming.
  • Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus).
  • Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting.
  • Excellent problem-solving, organizational, analytical, and critical thinking skills.
  • Strong leadership skills and ability to influence change.
  • Ability to provide training and coaching to lower-level employees.
  • Experience in facilitating change, including collaboration with management and executive stakeholders.
  • Strict attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Ability to manage competing priorities in a fast-paced environment.
  • Must be able to work in a team environment, including participating and presenting at meetings, including with external representatives.
  • Ability to provide guidance to others on area of expertise.
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
What We Offer

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $145,000 to $205,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Career website.

Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer, including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement: Edwards Lifesciences is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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