Senior Statistical Programmer FSP

Cytel; Frankfort (KY); On-site; USD 95,000 - 140,000; Full time

Job summary

Cytel Inc. is seeking a Senior Statistical Programmer to contribute to one or more Phase I-IV clinical trials while working remotely.

You will leverage advanced SAS programming and CDISC SDTM/ADaM expertise to develop, validate and deliver analysis datasets, tables, listings and figures for safety and efficacy data. You will collaborate with cross-functional teams across the global sponsor landscape, support submissions, and assume lead duties when required.

Qualifications

• Bachelor’s degree in Statistics, Computer Science, Mathematics or related field.
• At least 8 years of SAS programming with clinical trial data; 6+ years with a master's.
• Study lead experience preferred.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing CDISC SDTM/ADaM standards.
• Strong QC/validation skills.
• Good ad-hoc reporting skills.
• Proficiency in Efficacy analysis.
• Experience with drug development life cycle and submissions (define.xml).
• Experience supporting immunology, respiratory or oncology studies is a plus.
• Excellent analytical and troubleshooting skills.
• Ability to deliver quality outputs on tight timelines.
• Ability to work with a globally dispersed team.

Responsibilities

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data
• Applying strong understanding/experience of Efficacy analysis
• Creating and reviewing submission documents and eCRTs
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Performing lead duties when called upon
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change

Skills

Data manipulation

Analysis and reporting

Ad-hoc reporting

Efficacy analysis

QC/validation

Communication with cross-functional团队

Education

Bachelor's degree in Statistics, Computer Science, Mathematics

Tools

SAS

CDISC SDTM/ADaM

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 Senior 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:

As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.

Our values

• We believe in applying scientific rigor to reveal the full promise inherent in data.

• We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.

• We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.

• We prize innovation and seek intelligent solutions using leading-edge technology.

How you will contribute:

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming

• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)

• Production and QC / validation programming

• Generating complex ad-hoc reports utilizing raw data

• Applying strong understanding/experience of Efficacy analysis

• Creating and reviewing submission documents and eCRTs

• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries

• Performing lead duties when called upon

• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.

• Being adaptable and flexible when priorities change

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:

• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.

• At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.

• Study lead experience, preferably juggling multiple projects simultaneously preferred.

• Strong SAS data manipulation, analysis and reporting skills.

• Solid experience implementing the latest CDISC SDTM / ADaM standards.

• Strong QC / validation skills.

• Good ad-hoc reporting skills.

• Proficiency in Efficacy analysis.

• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.

• Submissions experience utilizing define.xml and other submission documents.

• Experience supporting immunology, respiratory or oncology studies would be a plus.

• Excellent analytical & troubleshooting skills.

• Ability to provide quality output and deliverables, in adherence with challenging timelines.

• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

Cytel Inc. is an Equal Employment /Affirmative 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.