Contractor - Senior/principal statistical programmer - Remote
This is a Contractor - Senior statistical programmer - Remote position in a pharmaceutical company. This position will play a key role in the development, validation, and maintenance of clinical trial data analyses.
This position ensures compliance with CDISC standards, adherence to regulatory requirements, and efficient execution of statistical programming deliverables. The role involves developing and validating datasets, tables, listings, and figures (TLFs) to support drug development and regulatory submissions for multiple indications.
Key Responsibilities
Develop and validate
SDTM
and
ADaM
datasets in accordance with
CDISC standards
.
Generate high-quality
tables, listings, and figures (TLFs)
for clinical study reports and regulatory submissions.
Ensure the accuracy, quality, and timeliness of statistical analyses and deliverables.
Perform rigorous quality control (QC) checks on all programming outputs.
Troubleshoot and resolve data and programming issues efficiently.
Collaborate with cross-functional study teams to support accurate and consistent data reporting.
Promote programming best practices by demonstrating strong technical expertise in statistical programming environments and tools.
Lead, mentor, and provide guidance to junior programming staff, fostering technical and professional development.
Ensure full compliance with regulatory submission requirements and CDISC standards (SDTM, ADaM).
Qualifications
Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field.
Minimum
10 years of relevant experience
in the biopharmaceutical, biotechnology, or CRO industry. Experience in late-phase (phase III) trials is highly desirable.
Proficiency in SAS programming
; familiarity with
R
is a plus.
Prior
CNS experience
is a plus.
Hands-on experience with raw datasets, SDTM, and ADaM dataset development.
Strong analytical, problem-solving, and communication skills (both verbal and written).
Ability to work effectively in a cross-functional environment, proactively influencing teams with innovative clinical development strategies.
Apply tot his job
Apply To this Job
This position ensures compliance with CDISC standards, adherence to regulatory requirements, and efficient execution of statistical programming deliverables. The role involves developing and validating datasets, tables, listings, and figures (TLFs) to support drug development and regulatory submissions for multiple indications.
Key Responsibilities
Develop and validate
SDTM
and
ADaM
datasets in accordance with
CDISC standards
.
Generate high-quality
tables, listings, and figures (TLFs)
for clinical study reports and regulatory submissions.
Ensure the accuracy, quality, and timeliness of statistical analyses and deliverables.
Perform rigorous quality control (QC) checks on all programming outputs.
Troubleshoot and resolve data and programming issues efficiently.
Collaborate with cross-functional study teams to support accurate and consistent data reporting.
Promote programming best practices by demonstrating strong technical expertise in statistical programming environments and tools.
Lead, mentor, and provide guidance to junior programming staff, fostering technical and professional development.
Ensure full compliance with regulatory submission requirements and CDISC standards (SDTM, ADaM).
Qualifications
Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field.
Minimum
10 years of relevant experience
in the biopharmaceutical, biotechnology, or CRO industry. Experience in late-phase (phase III) trials is highly desirable.
Proficiency in SAS programming
; familiarity with
R
is a plus.
Prior
CNS experience
is a plus.
Hands-on experience with raw datasets, SDTM, and ADaM dataset development.
Strong analytical, problem-solving, and communication skills (both verbal and written).
Ability to work effectively in a cross-functional environment, proactively influencing teams with innovative clinical development strategies.
Apply tot his job
Apply To this Job