Technical Officer – Biostatistics & Programming
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Department: Biostatistics & Programming
Job Type: Full-Time
CTC: ₹4 LPA – ₹8 LPA
JOB OVERVIEW
The Technical Officer – Biostatistics & Programming is responsible for supporting statistical activities for late-phase clinical trials, including study design, sample size estimation, randomization, statistical analysis planning, statistical programming, and preparation of statistical outputs. The role involves developing Statistical Analysis Plans (SAPs), generating randomization schedules, supporting IWRS activities, programming and reviewing Tables, Listings, and Figures (TLFs), contributing to Clinical Study Reports (CSRs), and providing statistical support for regulatory submissions while ensuring compliance with ICH-GCP guidelines and applicable regulatory requirements.
KEY RESPONSIBILITIES
Biostatistical Analysis
Perform statistical analysis for late-phase clinical trials.
Estimate sample size for clinical studies.
Support study design and statistical methodology.
Conduct statistical evaluations of clinical trial data.
Provide statistical inputs during study planning.
Clinical Trial Design
Support protocol development with statistical recommendations.
Assess study feasibility from a statistical perspective.
Contribute to clinical trial design and methodology.
Review statistical aspects of study protocols.
Ensure scientifically robust study designs.
Randomization & IWRS Support
Generate randomization schedules for clinical studies.
Support Interactive Web Response System (IWRS) implementation.
Verify randomization procedures and outputs.
Assist with treatment allocation strategies.
Ensure compliance with study randomization requirements.
Statistical Programming
Develop and review statistical programs using SAS.
Generate Tables, Listings, and Figures (TLFs).
Validate statistical programming outputs.
Perform quality checks on statistical deliverables.
Support analysis dataset creation where required.
Statistical Documentation
Draft Statistical Analysis Plans (SAPs).
Provide statistical inputs for Clinical Study Reports (CSRs).
Prepare statistical documentation for clinical studies.
Maintain statistical programming documentation.
Ensure audit-ready statistical records.
Regulatory Support
Respond to regulatory statistical queries.
Support statistical sections of regulatory submissions.
Ensure compliance with ICH-GCP and regulatory guidelines.
Collaborate with regulatory affairs during submissions.
Provide statistical expertise during audits and inspections.
Cross-Functional Collaboration
Collaborate with Clinical Operations and Data Management teams.
Work closely with programmers and statisticians.
Support project teams throughout the study lifecycle.
Participate in study planning and review meetings.
Contribute to continuous process improvement initiatives.
EDUCATIONAL QUALIFICATIONS
Required
M.Sc. in Statistics
Preferred
SAS Advanced Certification
SAS Viya Certification
EXPERIENCE REQUIREMENTS
Required
Experience working as a Biostatistician in:
Late-Phase Clinical Trials
Clinical Research
Biostatistics
Statistical Programming
Preferred
Experience with clinical trial statistical analysis.
Experience preparing Statistical Analysis Plans (SAPs).
Experience generating randomization schedules.
Experience supporting regulatory submissions.
CRO or pharmaceutical industry experience.
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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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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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 :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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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 :
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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 :
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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 :
Mississauga | Renfrew | North York | Uxbridge | Australia | Richmond Hill |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 :
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 :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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