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Principal Programmer, Statistical Programming

Lifelancer

**
United States
Full Time
Posted 8 days ago

Job Title: Principal Programmer, Statistical Programming (Remote)

Job Location: Boston, MA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Job Description

General Summary:

The Principal Statistical Programmer works with management to delegate tasks appropriately, track progress, and provide expert technical support to team members. In addition, the Principal Statistical Programmer is a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer.

Key Duties and Responsibilities:

  • Works regularly with advanced features of SAS (including interfacing ability with other software applications and operating system tools)
  • Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group
  • Demonstrates in-depth knowledge of clinical development and medical data
  • Solves complex clinical trial reporting problems and demonstrates technical proficiency and exercises judgment in supporting daily operations and ensuring that study tasks are completed accurately and in a timely manner
  • Engages with a variety of other functions, including Statistical Programmers, Biostatisticians, Data Management, and other departments engaged in providing data and submission-related activities, often at Senior Management levels
  • Creates all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS/ISE
  • Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations
  • Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
  • Participates in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies

Knowledge and Skills:

  • Proficiency in all SAS language, procedures, and functions commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
  • Intermediate knowledge of CDISC Standards
  • Intermediate knowledge of clinical trials
  • Regulatory submission experiences
  • Effective communication (written and verbal) skills to explain difficult information

Education and Experience:

  • Bachelors degree in a Scientific Discipline
  • Typically requires 5+ for M.S. or above and 8+ years for B.S. years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization

Pay Range 136,960.00 – 205,440.00 USD annually

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Pay Range:

$149,200 - $223,800

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Remote-Eligible

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at



This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

Originally posted on Himalayas

Statistical Programmer 2 - UK/Serbia - Remote

Lifelancer

**
United States
Full Time
Posted 15 days ago

Job Title: Statistical Programmer 2 - UK/Serbia - Remote

Job Location: Virtual Serbia

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What Global Programming does at Worldwide

The Worldwide team is an experienced and diverse group of Programmers who collaborate together as one, both via regularly scheduled group meetings to discuss issues, and impromptu one-on-one discussions between colleagues to discuss a particular topic.

As a Statistical Programmer on a project – you will be working with statisticians, sponsors, the wider study team and your own team of programmers, ensuring the data and output delivered for a study meets industry, regulatory submission and quality standards. As a Statistical Programmer at Worldwide, your analytical skills and ability to both program and understand / interpret data are the keys to success, and you will have the opportunity to continually grow your knowledge in SAS and CDISC across all phases and multiple therapy areas.

What you will do

  • Develop,testand execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables,figuresand listings (TFL).

  • Perform review of the clinical database specification, data transfer agreement/specification, programming related parts of Statistical Analysis plan including TFL shells for medium complexity studies.

  • Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells and other specifications, e.g. patient profiles, OPS reports.

  • Develop electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide) for medium complexity studies.

  • Serve as a programming project lead on medium complexity studies (e.g.multy-part phase I study, parallel group phase II/III study with multiple endpoints) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources and competing project priorities with line manager or mentor support. Ensure budget and scope of project work remain aligned.

What you will bring to the role

  • Must be computer literate and numerate with a willingness to adapt to various computer systems.

  • Hands-on expert level project statistical programmer experienced in providing programming leadership to projects.

  • Statistical programming skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.

Your experience

  • Educated to degree level or equivalent.

  • Advanced SAS programming skills with knowledge in SAS/Macro, Proc Report and ODS. Good working knowledge in SAS/Graph, Proc SQL.

  • Minimum3 yearsofpreviousrelated experience.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.



This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

Originally posted on Himalayas

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