Principal Statistical Programmer

Cytel; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to dedicate to a global pharmaceutical client, delivering rigorous programming for clinical development across therapeutic areas.

You will generate SDTM/ADaM specs, write SAS programs for datasets, listings, and tables, and supervise CRO programming to ensure high quality outputs. You will work with FDA/ICH guidelines and contribute to regulatory submissions.

This role emphasizes independence, ownership, and collaboration within a global team.

Qualifications

• Bachelor's degree in Computer Science, Statistics, or related field.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma or similar.
• Excellent SAS programming skills and CDISC standards experience.
• Experience with FDA/ICH regulatory submissions and data standards.
• Strong written and verbal communication with leadership abilities.

Responsibilities

• Generate SDTM/ADaM specifications and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, and tables with statistics.
• Deliver high quality programming outputs and maintain reproducible processes.
• Oversee CRO programmers to ensure timely, compliant data deliverables.
• Support creation of CSR, regulatory submissions, DSURs and exploratory analyses.

Skills

SAS programming

CDISC SDTM/ADaM

Clinical data analysis

Regulatory submissions

Team leadership & communication

Education

Bachelor's degree in Computer Science, Statistics, or related field

Tools

R

Python

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 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 trial

As a Principal Statistical Programmer, your responsibilities will include

• e:
  Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple stu
• diesDevelop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex gr
• aphsDeliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ n
• eedsParticipate in overseeing CRO’s statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timel
• inesSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory anal
• ysesUnderstand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissi
• ons.Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and ma
• crosParticipate in the development of CRFs, edit check specifications, and data validation p
• lansProvide review and/or author data transfer specifications for external vendor
• dataCollaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and g
• oalsProvide review and/or author SOPs and/or Work Instructions related to statistical programming pract

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 pref
• erred7+ 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 st
• udiesExceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development enviro
• nmentExtensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regul
• ationExperience supporting regulatory submissions, interacting with the FDA and/or global regulatory author
• itiesMust be able to work independ
• entlyOutstanding communication skills (written and verbal) and strong leadership s

Preferred Qualifications (nice to have)

• have)Prior work experience with pharmacokinetic data and the neuroscience f
• ield,proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux and