Top 14 Programming Writer Ii Jobs

Senior Principal Statistician
Jazz Pharmaceuticals —Philadelphia, PA
- $156,000 - $234,000 a year
- Remote
- Analysis skills
- Doctor of Philosophy
- Senior level
- Health insurance
- Dental insurance
Systems Analyst II
Loyola University Chicago —Maywood, IL
- $90,000 - $95,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Customer service
Computer Software Analyst II - #76-26
Newport-Mesa Unified School District —Costa Mesa, CA
- $9,851.92 - $11,975.08 a month
- 8 hour shift
- Computer science
- Computer Science
- Research
- Paid holidays
- Health insurance
14d
Honors Advisor
Syracuse University —Syracuse, NY
- $62,400 - $64,270 a year
- Online Application
- Mid-level
- Microsoft Office
- Master's degree
12d
Wireless Requirements Specialist II
EchoStar —Englewood, CO
- $63,150 - $90,000 a year
- Full-time
- Pass drug screening
- Mid-level
- Analysis skills
- Health savings account
- Employee stock purchase plan
Software Engineer 2
RealmOne —Maryland
- $166,000 - $214,000 a year
- Full-time
- Computer Science
- Mid-level
- Math
- Paid training
- Paid parental leave
Program Coodinator II (Provider Network Analyst) / 61047841
State of South Carolina —Richland County, SC
- $52,100 - $60,000 a year
- Overtime
- Word processing
- System design
- Mid-level
- Paid holidays
- Disability insurance
9d
Sr Test Automation Engineer I
Starkey Laboratories —Eden Prairie, MN
- $93,940 - $125,000 a year
- Management
- Computer literacy
- Bachelor of Science
- Paid parental leave
- Paid holidays
Quick Apply
Director of the Writing Center
Saginaw Valley State University —University Center, MI
- Full-time
- English
- Master's degree
- University
JDE Support Analyst
Dynamic Systems Resources —Chicago, IL
- Full-time
- Microsoft Excel
- Microsoft Access
- Microsoft Outlook
Literacy Coach (K-5) - Trimble Local School District
Athens-Meigs Educational Service Center —Chauncey, OH
- Full-time
- School experience
- Teaching Certification
- Mid-level
8d
Machine Learning Engineer II
Mimecast —Columbus, OH
- $124,000 - $186,000 a year
- Full-time
- Hybrid work
- Computer Science
- Mid-level
- Office
Sr. Associate, Credit – ABF – Product Specialist
Oaktree Capital Management, L.P. —Los Angeles, CA
- $150,000 - $225,000 a year
- Full-time
- Writing skills
- Bachelor's degree
- Senior level
- Opportunities for advancement

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Senior Principal Statistician

Jazz Pharmaceuticals -
Philadelphia, PA

Apply Now

Job Details

$156,000 - $234,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Vision insurance

Qualifications

Hypothesis testing
Biostatistics-based research
SAS
Design of experiments
R
Drug regulation
SAS language
ICH guidelines
Inferential statistics
Pharmaceutical company experience
CDISC standards
Clinical data analysis
Clinical trial support in drug product development
Project leadership
Statistical significance testing
Biostatistical modeling

Full Job Description

The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation. The Senior Principal Statistician will provide timely and scientifically sound statistical expertise to clinical development projects and develop and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations. The Senior Principal Statistician will manage work done by statistics and programming external vendors.

Essential Functions

Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
Collaborate with cross-functional team members to meet study any recurring report timelines.
Support the development and implementation of study protocols.
Review and provide input to data capture systems and participate in their validation.
Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.
Write statistical analysis plans, review statistical analysis plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses.
Prepare for and attend meetings with regulatory agencies.
Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices.
Review timelines and analysis plans for CRO work to ensure timeliness and quality deliveries.

Review and validate CRO deliverables.
Act as the statistical subject matter expert with medical writers and other colleagues in the production of clinical reports, integrated summaries, and other documents.
Respond to statistical questions from regulatory agencies.

Required Knowledge, Skills, and Abilities

Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis.
Experience in using SAS and R; knowledge of other statistical applications and programming languages a plus.
Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards.
Able to work in a fast-paced, flexible, team-oriented environment.
Possess excellent interpersonal and communication skills (written and verbal).
Strong attention to detail with a view to bring studies to a quality conclusion.
Flexible, positive, creative thinker, good communicator.
Work without close supervision. Well-developed time management skills are important.

Required/Preferred Education and Licenses

MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry.
PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry.
Knowledge of drug development regulations pertinent to statistical analysis.
Knowledge of the oncology or hematology therapeutic area is preferred
Bayesian and adaptive design experience is preferred.
Proficient SAS & R programming skills, solid understanding of CDISC models and standards.
Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.

#LI-Remote

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $156,000.00 - $234,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.

Apply Now

Refine Your Search

Programming Writer Ii jobs

Senior Principal Statistician

Systems Analyst II

Computer Software Analyst II - #76-26

Honors Advisor

Wireless Requirements Specialist II

Software Engineer 2

Program Coodinator II (Provider Network Analyst) / 61047841

Sr Test Automation Engineer I

Director of the Writing Center

JDE Support Analyst

Literacy Coach (K-5) - Trimble Local School District

Machine Learning Engineer II

Sr. Associate, Credit – ABF – Product Specialist

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