ClinChoice · 4 months ago
Associate Director, programming permanent role (Hybrid)
United States
Full-time
Hybrid
Entry, Mid, Senior Level, Lead/Staff, Director/Executive
10+ years expClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They are seeking an Associate Director of Statistical Programming to lead statistical programming activities for clinical trial projects, manage programmers and CROs, and ensure high-quality data deliverables in a timely fashion.
BiotechnologyConsultingHealth CarePharmaceutical
Responsibilities
Serve as a lead statistical programmer on one or more clinical studies
Provide statistical programming oversight to programming vendors
Review and validate datasets and TFLs programmed by vendors
Work collaboratively with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data deliverables in timely fashion
Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications as appropriate
Participate in developing and implementing statistical programming processes and standards
Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents and provide expert feedback from functional perspective
Build and mentor a team of programmers to support clinical trials and pipelines
Generate ad hoc analyses on ongoing basis
Qualification
Required
Master's Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines
A minimum of 10 years' experience in progressive and relevant clinical trial programming experience in biotech/pharma industry
Advanced SAS programming skills and experience in other statistical software, such as R, etc
Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies
Excellent organizational skills and ability to prioritize tasks
Excellent communication and interpersonal skills
Experience managing CROs and other data vendors
Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
Ability to keep pace in a fast-moving organization
Advanced knowledge of state-of-art statistical programming methods in clinical study setting
Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
Experience working in a remote virtual environment
Ability and willingness to travel per business needs (at least 4 – 8 times per year)
Preferred
Phase 3 and BLA submissions experience preferred
Company
ClinChoice
ClinChoice is a Reaserch and Deveiopment platform that develops innovative drugs and devices.
1001-5000 employees
H1B Sponsorship
ClinChoice has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (28)
2023 (21)
2022 (25)
2021 (35)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$212MKey Investors
Legend CapitalGoldman Sachs
2022-07-04Series E· $150M
2019-10-25Series D· $62M
2019-05-01Series C
Leadership Team
John Balian, MD
Chief Executive Officer
Recent News
2025-11-18
2023-07-18
Bloomberg.com
2023-07-07
Company data provided by crunchbase