Role Overview
The Senior Manager 1 – Statistical Programming provides strategic leadership, technical expertise, and people management support for clinical programming activities across multiple studies and therapeutic areas. The role is responsible for ensuring high-quality programming deliverables, regulatory submission readiness, CDISC compliance, and team development.
Key Responsibilities
Statistical Programming Leadership
Lead statistical programming activities across multiple clinical studies and projects.
Ensure timely delivery of high-quality programming outputs.
Drive programming strategy for assigned therapeutic areas, compounds, or indications.
Manage study timelines, priorities, and resource planning.
CDISC Standards & Data Deliverables
Develop and maintain programming documentation.
Create and review:
SDTM Mapping Specifications
ADaM Specifications
Ensure compliance with CDISC, TAUG, and regulatory standards.
SAS Programming & Analysis
Develop and oversee SAS programs for:
SDTM datasets
ADaM datasets
Tables, Listings, and Figures (TLFs)
Support ad-hoc and post-hoc analyses.
Review programming deliverables for quality and compliance.
Regulatory Submission Support
Lead preparation of submission packages including:
aCRF
define.xml
cSDRG
ADRG
ARM
Pinnacle 21 (P21) validation outputs
Support submissions to:
FDA
EMA
PMDA
Other global regulatory agencies
Standards & Process Improvement
Contribute to:
Statistical programming standards
SOP development
Standard macro development
Process optimization initiatives
Act as a Subject Matter Expert (SME) for CDISC implementation and regulatory requirements.
Cross-Functional Collaboration
Partner with:
Biostatistics
Data Management
Clinical Operations
Regulatory Affairs
Medical Writing
External vendors
Address health authority queries and submission-related issues.
People Management & Mentorship
Manage, coach, and mentor junior programmers and new hires.
Support performance development and career growth of team members.
Foster a collaborative and positive working environment.
Provide technical guidance on complex programming and CDISC-related issues.
Required Skills
Technical Skills
Advanced SAS Programming
CDISC SDTM & ADaM
Pinnacle 21 Validation
eCTD Submission Standards
Regulatory Submission Packages
Knowledge of:
R Programming (preferred)
Python (preferred)
Clinical & Regulatory Knowledge
Clinical Trial Design and Conduct
Statistical Concepts and Methodologies
NDA/ANDA Submissions
FDA, EMA, PMDA Requirements
CDISC and TAUG Standards
Leadership Skills
Team Management
Mentoring & Coaching
Stakeholder Management
Strategic Planning
Project Leadership
Resource Management
Soft Skills
Communication
Problem Solving
Decision Making
Collaboration
Innovation
Accountability
Seniority Level
Senior Management / People Manager
This role is typically one level above a Programming Manager and may oversee multiple studies, programmers, or a functional programming team.
Equivalent Market Titles
Senior Manager, Statistical Programming
Senior Programming Lead
Associate Director, Statistical Programming
Functional Lead, Statistical Programming
Clinical Programming Manager (Senior Level)
Experience Required
12+ years of Statistical Programming experience
Experience in Biotechnology, Pharmaceutical, CRO, or Healthcare industries
Prior experience in people management, mentoring, and team leadership preferred
Educational Qualification
Bachelor's degree in:
Statistics
Computer Science
Mathematics
Engineering
Life Sciences
Related disciplines
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Remote, India | Siliguri |Illinois :
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Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Lake Charles | Shreveport |Nevada :
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Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Sao paulo | Brazil |Attica :
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Greece |North Island :
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New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
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Manila |Croatia :
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Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
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Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Tel Aviv | Netanya | Yavne | Kfar Saba |Remote :
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Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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Warsaw |
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