Senior Manager – Real World Evidence (RWE) and Epidemiology
Location: Mumbai, India – Mumbai Development Center (EPD)
Organization: Abbott
Department: Research and Development
Employment Type: Full-Time
Job Overview
The Senior Manager – Real World Evidence (RWE) and Epidemiology is responsible for delivering advanced methodological and epidemiological expertise to support Real-World Evidence generation within the Established Pharmaceuticals Division (EPD). This role contributes to clinical development and medical affairs activities, supports observational and interventional research projects, and ensures compliance with international and local regulatory requirements as well as organizational policies.
The position involves designing, analyzing, and reporting observational clinical studies, managing outsourced research activities, and transforming real-world data into scientifically robust evidence to support pharmaceutical development and lifecycle management strategies.
Key Responsibilities
Real-World Evidence Strategy and Study Design
Lead the design, analysis, and reporting of observational clinical studies, including epidemiological surveys, case-control studies, cross-sectional studies, registry studies, and secondary database research.
Provide methodological leadership across multiple research projects and therapeutic areas, primarily focusing on RWE studies.
Define appropriate statistical methodologies, endpoints, and sample size calculations for clinical studies.
Develop and review statistical components of clinical study protocols to minimize bias and confounding in real-world data analysis.
Drive strategies to generate high-quality real-world evidence from real-world data through advanced analytical approaches.
Statistical Analysis and Research Oversight
Oversee outsourced research activities conducted by Contract Research Organizations (CROs).
Review and approve statistical analysis plans, database lock processes, and clinical study outputs including tables, listings, and figures.
Participate in data reviews and ensure appropriate conduct of statistical analyses for clinical development studies.
Ensure accurate interpretation and communication of research findings in collaboration with medical teams.
Regulatory and Scientific Support
Support regulatory dossier submissions by addressing statistical and methodological queries.
Ensure compliance with global regulatory standards and organizational research policies.
Provide expert review of epidemiological and methodological evidence from scientific literature and external research sources.
Represent biometrics and methodological expertise in the review of Health Economics and Outcomes Research (HEOR) studies, pharmacoeconomic models, and global value dossiers.
Stakeholder Engagement and Scientific Communication
Present research findings at investigator meetings, key opinion leader engagements, and regulatory discussions.
Communicate complex epidemiological and statistical concepts to both technical and non-technical stakeholders.
Contribute to behavioral design and adherence studies, including projects involving digital health and telehealth solutions.
Research Excellence and Knowledge Development
Stay updated with emerging methodologies, epidemiological practices, and regulatory developments in RWE and clinical research.
Participate in scientific conferences, training programs, and professional development initiatives.
Share insights, literature updates, and regulatory guidance with internal teams to support continuous learning and innovation.
Role Scope and Accountabilities
Accountable for the design, statistical analysis, and reporting of observational clinical studies, including sample size justification.
Responsible for methodological review of study protocols across affiliates.
Provide strategic epidemiological support to Real-World Evidence initiatives and research programs.
Education Requirements
PhD or MSc in Biostatistics, Statistics, Mathematics, Epidemiology, Health Economics, or a related discipline.
Candidates with a Statistics background should have additional training in epidemiology and Real-World Evidence methodologies.
Candidates with an Epidemiology background should have additional training in statistical methods.
Experience Requirements
Minimum 5 years of experience in a pharmaceutical or healthcare research environment.
Demonstrated expertise in designing and conducting observational studies such as registries, case-control studies, secondary database studies, and pragmatic trials.
Experience in transforming real-world data into real-world evidence using advanced statistical methodologies, including Target Trial Emulation, G-computation, E-values, or Targeted Maximum Likelihood Estimation.
Hands-on experience with statistical analysis tools such as SAS and/or R.
Strong ability to communicate epidemiological concepts to non-technical stakeholders.
Knowledge of Health Economics and Outcomes Research (HEOR) is preferred.
Familiarity with behavioral science models and adherence research is advantageous.
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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Delhi | India | 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 :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
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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 | Uxbridge | North York | Australia | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |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 :
Tartu | Estonia |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 :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Netanya | Yavne | Kfar Saba | Tel Aviv |Remote :
Remote - Africa | Lousiana | Faridabad | Belgium | Manipal | Remote - Europe | Nairobi | McFarland | Hungary | French | Zaragoza | Blue Bell | Hammond | Melbourne | Ireland | Slovakia | Green Way | Regulatory Labeling Manager (NA and LATAM Only) | Leinster | Remote, USA | Lenexa | Springville | Thailand | Tulsa | Xzagreb | Minnesota | Bountiful | Medan | Bishop | Remote - South America (Latin Americal) | Switzerland | Remote - Middle East | Victoria | Riga | Texas | Castlebar | Remote |Republic of Colombia :
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Bucharest |Buenos Aires :
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Ciudad de México | New Mexico |Dubai :
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Jeddah | Riyadh | King Abdullah Economic City | Najran | Khulais | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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