Senior Statistical Programming Lead, Clinical Trials

PTC Therapeutics, Inc.; New York (NY); On-site; USD 147,000 - 185,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Statistical Programming to drive programming activities for clinical development programs and oversee CRO relationships. The role develops SPS/SAP procedures and supports CDISC-compliant data analysis across trials.

The candidate will work cross-functionally with internal teams and external vendors, ensuring regulatory compliance and timely deliverables while contributing to data-driven decisions in a fast-paced environment.

Qualifications

• Master’s degree in a quantitative science discipline with 5+ years of experience in statistics or statistical programming in pharma/CRO.
• Demonstrated SAS programming skills (Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS).
• Working knowledge of R and CDISC experience.
• Knowledge of clinical data analysis and reporting process in drug development.
• Excellent verbal and written communication and ability to work independently in a fast-paced environment.
• Experience supporting NDAs/MAAs submissions and CRO oversight.

Responsibilities

• Leads statistical programming activities for assigned clinical development studies and programs.
• Ensures timely statistical analyses per protocols and SAPs, through direct work or CRO oversight.
• Participates in study team meetings and communicates statistical issues to development teams.
• Participates in CRO selection, evaluation, and oversight.
• Reviews CRFs, CRF annotations, SAPs, and TLGs for accuracy and alignment with deliverables.
• Interacts with CROs and vendors to ensure accurate data analyses and outputs.
• Creates or reviews derived dataset specifications and related analysis datasets.
• May develop SOPs and training guidelines related to statistical programming.
• Performs other tasks as needed by management.

Skills

SAS programming

R programming

CDISC

Statistical analysis

Education

Master’s degree in quantitative science

Tools

SAS

R

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Statistical Programming to drive programming activities for clinical development programs and oversee CRO relationships. The role develops SPS/SAP procedures and supports CDISC-compliant data analysis across trials.

The candidate will work cross-functionally with internal teams and external vendors, ensuring regulatory compliance and timely deliverables while contributing to data-driven decisions in a fast-paced environment.