1478# Associate Director, Statistical Programming Permanent Role - Hybrid jobs in United States
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ClinChoice · 11 hours ago

1478# Associate Director, Statistical Programming Permanent Role - Hybrid

positionWaltham, MA
timeFull-time
remoteHybrid
seniorityLead/Staff, Director/Executive
date8+ years exp

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. The Associate Director of Statistical Programming will lead programming activities, build scalable processes, and ensure high-quality deliverables for regulatory submissions in a hybrid role with a focus on strategic and technical leadership within the Biometrics team.

BiotechnologyConsultingHealth CarePharmaceutical
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H1B Sponsor Likelynote
Hiring Manager
Timothy Tanaka
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Responsibilities

Lead programming strategy across multiple clinical studies and development programs
Oversee and manage internal programmers and external vendors/CRO partners
Establish and maintain programming standards, processes, and best practices
Support planning, timelines, and resourcing for all programming activities
Provide oversight and hands-on support for the development and validation of:
SDTM, ADaM datasets
TLFs (Tables, Listings, Figures)
Integrated datasets for ISS/ISE
Ensure all deliverables meet regulatory, statistical, and quality requirements
Guide the implementation of programming workflows using SAS and/or R
Drive automation, reproducibility, and process efficiency within the programming team
Partner closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams
Serve as a key programming representative in study team meetings
Support regulatory submissions, including eCTD-ready deliverables, reviewer guides, and traceability documents

Qualification

SASCDISC standardsRegulatory submissionsRLeadershipCommunicationProject management

Required

Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field
8–12+ years of experience in clinical programming within pharma/biotech or CRO
Strong proficiency in SAS, with experience in R being a strong plus
Expert-level knowledge of CDISC standards (SDTM, ADaM)
Experience managing or overseeing programming teams and external vendors
Proven track record supporting regulatory submissions (FDA, EMA, PMDA, etc.)
Excellent communication, leadership, and project management skills

Company

ClinChoice

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ClinChoice is a Reaserch and Deveiopment platform that develops innovative drugs and devices.
dateFounded in 1995
location
Shanghai, Shanghai, CHN
people-size1001-5000 employees
web-link
https://www.clinchoice.com.cn

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 (18)
2024 (28)
2023 (21)
2022 (25)
2021 (35)
2020 (3)

Funding

Current Stage
Late Stage
Total Funding
$212M
Key Investors
Legend CapitalGoldman Sachs
2022-07-04Series E· $150M
2019-10-25Series D· $62M
2019-05-01Series C

Leadership Team

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John Balian, MD
Chief Executive Officer
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Recent News

PharmiWeb
ClinChoice Earns Global ISO 9001:2015 and ISO 14155:2020...
2025-11-18
PharmiWeb.com
ClinChoice Acquires CROMSOURCE, Solidifying its Position Globally
2023-07-18
Bloomberg.com
Goldman-Backed ClinChoice Considers Hong Kong IPO
2023-07-07
Company data provided by crunchbase