Real World Data Statistician I/II
Company: Alexion, AstraZeneca Rare Disease
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Work Model: Hybrid (Minimum 3 Days Office)
Job Level: Individual Contributor (C1/C2)
Job ID: R-252435
Position Overview
Alexion, AstraZeneca Rare Disease, is seeking a highly motivated Real World Data Statistician I/II to join its Epidemiology and Real-World Evidence (RWE) team.
This role focuses on generating high-quality regulatory-grade evidence from patient registries, disease registries, observational studies, electronic medical records (EMR), claims databases, and natural history studies. The successful candidate will support statistical analyses that inform regulatory submissions, scientific publications, post-marketing commitments, and evidence-generation strategies for rare disease programs.
The position offers an opportunity to work at the intersection of biostatistics, epidemiology, regulatory science, and real-world evidence, helping transform complex healthcare data into meaningful insights that improve patient outcomes.
Key Responsibilities
Real World Evidence (RWE) Generation
Support the development of real-world evidence from:
Disease Registries
Patient Registries
Natural History Studies
Electronic Medical Records (EMR)
Claims Databases
Observational Research Studies
Generate evidence supporting:
Regulatory submissions
Health authority interactions
Scientific publications
Post-authorization commitments
Clinical development strategies
Registry Evidence Strategy
Contribute to analytical strategies for registry-based evidence generation.
Support regulatory and scientific decision-making through robust statistical analyses.
Assist in developing evidence-generation plans across rare disease programs.
Support cross-functional efforts to maximize the value of registry data.
Statistical Analysis & Modeling
Perform advanced statistical analyses including:
Survival Analysis
Kaplan-Meier Analysis
Cox Proportional Hazards Models
Time-to-Event Analysis
Causal Inference Methods
Propensity Score Matching (PSM)
Inverse Probability Weighting (IPW)
Treatment Effect Estimation
Comparative Effectiveness Research
Longitudinal Data Analysis
Mixed Effects Models
Repeated Measures Analysis
Disease Progression Modeling
Registry-Specific Methodologies
Missing Data Management
Confounding Adjustment
Outcome Validation
Data Linkage Strategies
Cohort Construction
Sensitivity Analyses
Regulatory-Grade Statistical Deliverables
Support preparation of statistical outputs aligned with global regulatory expectations.
Contribute to development of:
Statistical Reports
Clinical Study Reports (CSRs)
Regulatory Briefing Documents
Health Authority Responses
Evidence Packages
Ensure compliance with:
FDA Real World Evidence Framework
EMA Registry Guidance
International Regulatory Standards
Methodology Development & Innovation
Support development and validation of innovative statistical methodologies.
Contribute to advancement of registry-specific analytical approaches.
Research emerging methods in pharmacoepidemiology and real-world evidence.
Participate in methodological discussions and knowledge-sharing initiatives.
Cross-Functional Collaboration
Collaborate closely with:
Epidemiologists
Clinical Development Teams
Regulatory Affairs
Statistical Programmers
Data Scientists
Registry Operations Teams
External Consultants
Academic Collaborators
Registry Investigators
to ensure methodological rigor and data quality.
Regulatory Support
Support analyses used in regulatory submissions.
Participate in preparation for health authority interactions and advisory meetings.
Ensure registry-derived evidence aligns with regulatory strategies and submission requirements.
Contribute to responses addressing regulatory questions and evidence requests.
Quality, Compliance & Reproducibility
Follow AstraZeneca and Alexion statistical standards and best practices.
Ensure reproducibility, transparency, and audit readiness of statistical analyses.
Maintain high standards for data integrity and documentation.
Support quality control and validation activities.
Scientific Communication
Communicate statistical concepts and findings clearly to cross-functional stakeholders.
Translate complex methodologies into clinically meaningful insights.
Contribute to presentations, scientific publications, and evidence-generation initiatives.
Support dissemination of study findings through conferences and peer-reviewed journals.
Required Qualifications
Education
Preferred
Master's Degree in:
Statistics
Biostatistics
Epidemiology
Public Health (Quantitative Focus)
Data Science
Related Quantitative Discipline
Alternative
Equivalent professional experience in statistical analysis and real-world evidence generation.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
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 :
Bavaria |Bavaria :
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 :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
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 :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Mississauga | Uxbridge | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Yavne | Tel Aviv | Netanya | Be'Er Sheva | Kfar Saba |Remote :
Melbourne | Medan | Thailand | Belgium | French | Perth | Remote - Africa | Nairobi | Regulatory Labeling Manager (NA and LATAM Only) | Minnesota | Remote - Middle East | Blue Bell | Manipal | Leinster | Springville | Tulsa | Hungary | Zaragoza | Ireland | Texas | Riga | Victoria | Castlebar | Lousiana | Xzagreb | Milwaukee | Faridabad | McFarland | Switzerland | Bountiful | Slovakia | Lenexa | Remote - South America (Latin Americal) | Hammond | Green Way | Bishop | Remote - Europe |Republic of Colombia :
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Bucharest |Buenos Aires :
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Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
Najran | Khulais | Rabigh | Riyadh | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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