Principal Statistical Programmer (FSP Remote)

Cytel; Helena (MT); Remote; USD 110,000 - 170,000; Full time

Job summary

Cytel seeks a Principal Statistical Programmer to work embedded with a global pharmaceutical client, under Cytel's guidance. You will lead programming for clinical development, supervise CROs, and ensure high-quality data deliverables.

You will develop SDTM/ADaM specs, create define.xml, reviewer’s guides, and complex tables/graphs using SAS and R, with emphasis on regulatory submissions and CDISC standards.

Qualifications

• Bachelor's degree in CS/DS/Math/Stats required or equivalent.
• 7+ years of experience as Statistical Programmer in Biotech/Pharma clinical development biometrics.
• Exceptional SAS programming skills in a clinical development environment.
• CDISC SDTM/ADaM and Define.xml expertise.
• Experience supporting regulatory submissions with FDA/ICH.
• Ability to work independently and lead teams.
• Strong written and verbal communication and leadership abilities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs with descriptive and inferential stats.
• Deliver high-quality statistical programming results and maintain SAS/R programs for programs' needs.
• Oversee CROs' statistical programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications and DSURs.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Create, maintain, validate standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans; provide data transfer specs.
• Collaborate with CROs, vendors, and internal teams to meet timelines.

Skills

SAS programming

CDISC standards (SDTM/ADaM)

Regulatory submissions

Independent work

Leadership

Communication

Biotech/Pharma experience

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

R

Python

Java

Shiny

Unix/Linux

Git

SAS

Job description

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.

As a Principal Statistical Programmer, your responsibilities will include:

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies

• Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs

• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs

• Participate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines

• Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses

• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.

• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros

• Participate in the development of CRFs, edit check specifications, and data validation plans

• Provide review and/or author data transfer specifications for external vendor data

• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals

• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred

• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies

• Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment

• Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation

• Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities

• Must be able to work independently

• Outstanding communication skills (written and verbal) and strong leadership skills

Preferred Qualifications (nice to have)

• Prior work experience with pharmacokinetic data and the neuroscience field,

• proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and git)

Cytel Inc. is an Equal Employment / Affiantative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.