Stark Pharma Solutions Inc
Lead Statistical Programmer - Pharma
Stark Pharma Solutions Inc, Washington, District of Columbia, us, 20022
Position Title:
Lead Statistical Programmer - Pharma
Location:
Remote
Experience:
8+ Years
Contract Duration:
24 Months
Job Summary We're looking for an experienced
Lead Statistical Programmer - Pharma
to lead statistical programming activities related to the development and maintenance of integrated clinical safety datasets across one or more compounds, indications, or therapeutic areas. The ideal candidate will collaborate with cross-functional teams including Statistics, Data Sciences, Pharmacovigilance, Medical Writing, and Clinical Operations to ensure accuracy, consistency, and regulatory compliance.
Key Responsibilities
Lead programming efforts for the creation and maintenance of integrated clinical safety datasets.
Develop and validate SDTM, ADaM, and TLF datasets for CSR, ISS, and ISE submissions.
Design and maintain ADaM specifications and SAS programs supporting ISS/ISE programming and regulatory submissions.
Oversee programming deliverables for IB, DSUR, PSUR, and Annual Safety Reports.
Ensure adherence to internal SOPs, department standards, and CDISC data standards.
Conduct quality checks for data consistency, accuracy, and compliance with statistical analysis plans.
Collaborate with statisticians, data managers, and pharmacovigilance teams to support safety and efficacy analysis.
Troubleshoot and optimize SAS code, macros, and utilities for efficiency.
Provide timely responses to data or programming requests with a high sense of ownership.
Support internal process improvements and ensure training compliance.
Required Skills & Experience
Strong SAS Programming skills, including data manipulation, macro writing, and debugging.
Proven experience in SDTM and ADaM dataset development and validation.
Experience with CDISC standards and regulatory submission requirements (FDA, EMEA).
Hands‑on experience supporting IB, DSUR, PSUR, ISS, ISE, and Study CSR deliverables.
Strong understanding of statistical analysis plans and derivation logic.
Excellent communication skills and ability to work collaboratively in cross‑functional teams.
Proven ability to manage multiple priorities and deliver high‑quality work under deadlines.
Education & Qualifications
BS or MS in Statistics, Computer Science, or related field.
Minimum 8 years of experience in SAS programming within the pharmaceutical or clinical research industry.
Demonstrated expertise in clinical trial data, regulatory standards, and programming best practices.
Seniority level Mid-Senior level
Employment type Contract
Job function Research, Analyst, and Information Technology
Industries Staffing and Recruiting
#J-18808-Ljbffr
Lead Statistical Programmer - Pharma
Location:
Remote
Experience:
8+ Years
Contract Duration:
24 Months
Job Summary We're looking for an experienced
Lead Statistical Programmer - Pharma
to lead statistical programming activities related to the development and maintenance of integrated clinical safety datasets across one or more compounds, indications, or therapeutic areas. The ideal candidate will collaborate with cross-functional teams including Statistics, Data Sciences, Pharmacovigilance, Medical Writing, and Clinical Operations to ensure accuracy, consistency, and regulatory compliance.
Key Responsibilities
Lead programming efforts for the creation and maintenance of integrated clinical safety datasets.
Develop and validate SDTM, ADaM, and TLF datasets for CSR, ISS, and ISE submissions.
Design and maintain ADaM specifications and SAS programs supporting ISS/ISE programming and regulatory submissions.
Oversee programming deliverables for IB, DSUR, PSUR, and Annual Safety Reports.
Ensure adherence to internal SOPs, department standards, and CDISC data standards.
Conduct quality checks for data consistency, accuracy, and compliance with statistical analysis plans.
Collaborate with statisticians, data managers, and pharmacovigilance teams to support safety and efficacy analysis.
Troubleshoot and optimize SAS code, macros, and utilities for efficiency.
Provide timely responses to data or programming requests with a high sense of ownership.
Support internal process improvements and ensure training compliance.
Required Skills & Experience
Strong SAS Programming skills, including data manipulation, macro writing, and debugging.
Proven experience in SDTM and ADaM dataset development and validation.
Experience with CDISC standards and regulatory submission requirements (FDA, EMEA).
Hands‑on experience supporting IB, DSUR, PSUR, ISS, ISE, and Study CSR deliverables.
Strong understanding of statistical analysis plans and derivation logic.
Excellent communication skills and ability to work collaboratively in cross‑functional teams.
Proven ability to manage multiple priorities and deliver high‑quality work under deadlines.
Education & Qualifications
BS or MS in Statistics, Computer Science, or related field.
Minimum 8 years of experience in SAS programming within the pharmaceutical or clinical research industry.
Demonstrated expertise in clinical trial data, regulatory standards, and programming best practices.
Seniority level Mid-Senior level
Employment type Contract
Job function Research, Analyst, and Information Technology
Industries Staffing and Recruiting
#J-18808-Ljbffr