Senior Statistical Programmer

Katalyst CRO; Cambridge (MA); Remote; USD 147,000 - 213,000; Full time

Job summary

A leading company in the pharmaceutical industry is looking for a Senior Statistical Programmer. This remote role requires advanced SAS programming skills and proficiency in CDISC standards to support clinical trials. Candidates with extensive experience in data manipulation and reporting are encouraged to apply for this mid-senior level position.

Qualifications

• At least 8 years of SAS programming experience with clinical trial data.
• Solid experience in CDISC SDTM/ADaM standards.
• Ability to work in a globally dispersed team.

Responsibilities

• Leverage SAS programming skills for Phase I-IV clinical trials.
• Generate and validate SDTM/ADaM datasets and TLFs.
• Communicate with cross-functional teams regarding project status.

Skills

SAS Programming

CDISC Standards

Data Manipulation

Efficacy Analysis

Ad-hoc Reporting

Education

Bachelor's Degree in Statistics, Computer Science, Mathematics

Job description

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• 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.
• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/Client), 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 arts.
• 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.
  
  

Responsibilities

• 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.
• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/Client), 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 arts.
• 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.
  
  

Requirements:

• 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.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing the latest CDISC SDTM / ADaM standards.
• 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
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Information Technology

• Industries

  Pharmaceutical Manufacturing

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