Senior Statistical Programmer

Responsibilities:

• Oversee programming activities outsourced to CROs, including development of SDTM, ADaM datasets, TFLs and other clinical data products.
• Ensure data outputs meet protocol and SAP specifications and comply with regulatory guidelines and CDISC standards. Secure their timely delivery per timeline and agreement.
• Write validation programs with SAS or R and perform rigorous quality checks to ensure accuracy and consistency.
• Communicate discrepancies or issues with internal study teams and CROs to address and resolve them in a timely manner.
• Develop statistical programs with SAS or R to generate datasets and TFL outputs to support ad hoc statistical analysis and regulatory reports such as DSUR and IB.
• Maintain clear and detailed documentation of associated programming activities.
• Hands-on experience with SDTM, ADaM datasets, and TFL production and validation for clinical data.
• Experiences with early-phase clinical trial development and CRO oversight are preferred
• Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.

Requirements:

• Bachelor's degree in computer science, Statistics, Engineering or Life Sciences related field.
• Minimum 4-5 years of experience in statistical programming within the pharmaceutical or clinical research industry.
• Thorough documentation keeping
• Team player; comfortable and effective in a collaborative research environment
• ISS/Client safety & efficacy experience is required.
• Experience creating define.xml and experience with Pinnacle 21 and specifications.
• SAS Certified Base and/or Advance Programmer experience is preferred.
• Proven experience in SAS programming including base SAS, SAS/Stat, SAS/Graph, macros, ODS.
• Strong organizational and time-management skills
• Excellent written and oral communication skills