Senior Statistical Programmer

Cytel; India; Remote; INR 2,200,000 - 3,800,000; Full time

Job summary

A leading biopharmaceutical organization is seeking a Senior Statistical Programmer to join their team remotely. The successful candidate will have extensive experience in SAS programming and a solid understanding of CDISC standards. You will contribute to Phase I-IV clinical trials focusing on data analysis, reporting, and validations. Candidates should possess a Bachelor's degree in relevant fields and have at least 8 years of experience in the pharmaceutical and biotech sectors. Strong analytical skills and cross-functional collaboration are essential for success in this role.

Qualifications

• At least 8 years of SAS programming experience in the pharmaceutical industry.
• Study lead experience managing multiple projects.
• Excellent analytical and troubleshooting skills.
• Experience with submissions and define.xml.

Responsibilities

• Perform data manipulation, analysis, and reporting on clinical trial data.
• Generate and validate SDTM and ADaM datasets.
• Communicate specifications and status with internal teams and clients.
• Create complex ad-hoc reports from raw data.
• Apply strong efficacy analysis understanding.
• Create and review submission documents and eCRTs.
• Coordinate with cross-functional teams and clients on project specs and status.
• Provide lead duties when needed.
• Collaborate effectively in a globally dispersed team.

Skills

SAS programming

CDISC standards

Data analysis

Efficacy analysis

Analytical skills

Troubleshooting skills

Education

Bachelor’s degree in Statistics, Computer Science, or Mathematics

Master's degree or higher

Tools

SAS

Job description

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.

Responsibilities

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

Qualifications

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.
• 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.