job Summary
The Manager II – Statistical Programming is responsible for leading statistical programming activities across one or more Phase I-IV clinical studies. This role involves managing end-to-end programming deliverables, ensuring compliance with CDISC standards and regulatory requirements, supporting global submissions, and collaborating with cross-functional teams to deliver high-quality outputs within established timelines.
The incumbent will serve as a subject matter expert (SME), contribute to programming standards and process improvements, and mentor junior programmers while supporting clinical development programs.
Key Responsibilities
Statistical Programming Leadership
Lead statistical programming activities for therapeutic areas, compounds, or indications across multiple studies.
Ensure timely delivery of high-quality programming outputs for assigned projects.
Plan, coordinate, and monitor programming activities throughout the study lifecycle.
Act as a programming lead and SME on assigned studies.
CDISC Standards & Dataset Development
Develop and maintain programming documentation according to organizational standards.
Create and review CDISC-compliant SDTM mapping specifications.
Develop ADaM specifications and associated documentation.
Ensure implementation of CDISC standards, TAUGs, and regulatory guidance.
Programming & Analysis Deliverables
Develop and oversee SAS programs for:
SDTM Datasets
ADaM Datasets
Tables
Listings
Figures (TLFs)
Support study reports, regulatory submissions, and ad hoc/post hoc analyses.
Perform end-to-end programming activities independently.
Regulatory Submission Support
Prepare and manage regulatory submission deliverables including:
Annotated CRF (aCRF)
Define.xml
cSDRG
ADRG
ARM
Handle Pinnacle 21 (P21) validation activities.
Support submissions to:
FDA
EMA
PMDA
Other global regulatory authorities
Address regulatory agency queries in collaboration with cross-functional teams.
Process Improvement & Standards
Develop and maintain standard and utility SAS macros.
Contribute to programming libraries, standards, and best practices.
Support continuous improvement initiatives within the programming function.
Study Documentation & Review
Participate in CRF annotation activities.
Review Statistical Analysis Plans (SAPs).
Review TLF specifications and outputs.
Ensure programming deliverables comply with quality standards and regulatory expectations.
Mentorship & Team Development
Mentor and coach junior programmers and new hires.
Provide technical guidance on SAS programming and CDISC implementation.
Support knowledge sharing and capability development across the team.
Educational Qualifications
Required
Bachelor’s Degree in:
Statistics
Computer Science
Mathematics
Engineering
Life Sciences
Related Scientific Discipline
Experience Requirements
Required
Minimum 4+ years of statistical programming experience.
Experience processing clinical trial data within:
Biotechnology Companies
Pharmaceutical Companies
CROs
Healthcare Research Organizations
Preferred
Prior Programming Team Lead (PTL) experience.
Experience supporting global regulatory submissions.
Required Skills & Competencies
Technical Skills
Advanced SAS Programming
CDISC SDTM & ADaM Standards
Pinnacle 21 Validation
Define.xml Development
TLF Programming
Clinical Trial Data Analysis
Regulatory Submission Support
NDA / ANDA Submission Knowledge
Preferred Technical Skills
R Programming
Python Programming
SAS Certifications
Domain Knowledge
Clinical Development Processes
Statistical Concepts & Methodologies
Clinical Trial Design
FDA, EMA & PMDA Guidelines
CDISC TAUG Implementation
eCTD, sdTCG, DSC Standards
Leadership & Behavioral Competencies
Team Leadership
Mentoring & Coaching
Problem Solving
Analytical Thinking
Stakeholder Management
Strong Communication Skills
Collaboration & Teamwork
Adaptability in Fast-Paced Environment
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Remote, India | Siliguri |Illinois :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
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Saarbrucken |Switzerland :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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