Safety Statistician, Manager
Location: Hyderabad, India
Work Mode: On-Site
Department: Biostatistics / Clinical Research
Job Overview
We are seeking an experienced Safety Statistician, Manager to provide statistical expertise in support of safety assessment activities across clinical development programs. This role involves analyzing and interpreting aggregate safety data from multiple clinical studies while collaborating with cross-functional teams to ensure high-quality safety evaluations and regulatory-compliant reporting.
The ideal candidate will possess strong expertise in biostatistics, clinical trial data analysis, safety signal evaluation, and advanced statistical methodologies to support evidence-based decision-making throughout the clinical development lifecycle.
Key Responsibilities
Safety Data Analysis and Assessment
Provide statistical expertise for the assessment and interpretation of aggregate safety data across multiple clinical studies and development programs.
Support safety evaluation activities throughout the clinical trial lifecycle.
Perform statistical analyses of safety data and contribute to the interpretation of findings.
Identify trends, patterns, and potential safety signals through exploratory and advanced analyses.
Safety Reporting and Documentation
Contribute to the development and execution of aggregated safety analysis plans.
Support safety assessment reporting activities and regulatory submissions.
Ensure accurate documentation of statistical methodologies, analyses, and conclusions.
Maintain compliance with internal procedures and industry standards.
Cross-Functional Collaboration
Collaborate with Safety Assessment Teams and other cross-functional stakeholders.
Provide statistical input for safety review discussions and decision-making processes.
Support the development of safety-related deliverables and presentations.
Work effectively with globally distributed teams and international stakeholders.
Statistical Methodology and Innovation
Develop and apply statistical methods and analytical tools for safety assessments.
Support the implementation of advanced analytical approaches and data visualization techniques.
Contribute to methodological improvements and process optimization initiatives.
Stay updated with emerging statistical methodologies, machine learning applications, and analytical innovations relevant to clinical safety assessment.
Quality and Compliance
Apply statistical principles, regulatory guidelines, and organizational standards to ensure high-quality analyses.
Ensure consistency, accuracy, and scientific rigor across all safety-related statistical outputs.
Adhere to all applicable Standard Operating Procedures (SOPs) and compliance requirements.
Required Qualifications
Education
MSc in Statistics, Biostatistics, or a related quantitative field.
PhD in Statistics, Biostatistics, or a related quantitative field.
Experience
Minimum 8+ years of industry experience in biostatistics, clinical research, pharmaceutical research, or related fields.
Technical Skills
Proficiency in statistical programming tools such as:
R
SAS
Strong knowledge of statistical design and analysis methodologies.
Experience performing statistical analyses within clinical development programs.
Preferred Qualifications
Clinical Research Experience
Experience working within pharmaceutical, biotechnology, CRO, or medical research environments.
Hands-on experience in clinical trial design, execution, and data analysis.
Experience conducting safety data analyses in clinical trial settings.
Advanced Analytics
Experience applying machine learning techniques to healthcare or clinical research data.
Knowledge of advanced statistical methodologies for safety signal detection and risk assessment.
Experience developing analytical applications and visualization tools.
Data Visualization
Experience developing or overseeing development of:
R Shiny applications
Interactive dashboards
Clinical safety visualization tools
Ability to communicate complex statistical findings through effective visualizations.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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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 :
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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 :
Australia | Richmond Hill | North York | Uxbridge | Mississauga | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |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 :
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 :
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Bangkok |Israel :
Yavne | Be'Er Sheva | Tel Aviv | Kfar Saba | Netanya |Remote :
McFarland | Faridabad | Perth | Xzagreb | Remote - South America (Latin Americal) | Springville | Remote - Africa | Bountiful | Manipal | Nairobi | Hungary | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Remote - Europe | Leinster | Minnesota | Belgium | Hammond | Riga | Zaragoza | Slovakia | Blue Bell | French | Tulsa | Texas | Lousiana | Medan | Ireland | Lenexa | Castlebar | Switzerland | Victoria | Melbourne | Thailand | Milwaukee | Bishop | Green Way |Republic of Colombia :
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Brentwood |Bucharest :
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Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
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King Abdullah Economic City | Jeddah | Rabigh | Najran | Khulais | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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