Principal Stat Programmer

10+ years

Not Disclosed

Hyderabad

10 Dec. 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Programmer (ADaM & TFL Specialist)
Location: IQVIA Laboratories

About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We foster innovation and create intelligent connections to accelerate the development of medical treatments that improve patient outcomes and population health. To learn more, visit IQVIA Careers.

Role Overview:
We are looking for highly experienced Programmers with a minimum of 10+ years of hands-on experience in ADaM (Analysis Data Model) and TFL (Tables, Figures, and Listings) programming. The ideal candidate should have experience with Oncology/Immunology studies, specifically with Efficacy ADaMs and TFLs, including ADTTE (Analysis of Time-to-Event), and key oncology efficacy endpoints such as PFS, OS, DOR, BOR, and ORR. Experience with Kaplan-Meier (KM) Plots, Waterfall Plots, and Forest Plots is required.

Key Responsibilities:

Programming & Analysis:
- Develop and maintain ADaM datasets and TFLs, ensuring compliance with industry standards (CDISC).
- Create ADTTE datasets and associated TFLs for oncology and immunology studies, including efficacy endpoints like PFS, OS, DOR, BOR, and ORR.
- Develop statistical outputs such as Kaplan-Meier Plots, Waterfall Plots, and Forest Plots to represent clinical data for efficacy analysis.
Study Support:
- Collaborate with statistical and clinical teams to design and execute statistical analysis plans.
- Ensure timely delivery of analysis outputs for Phase 2 and Phase 3 clinical trials.
Quality & Documentation:
- Ensure that all ADaM datasets and TFLs are generated according to CDISC standards and study protocols.
- Review, validate, and ensure the integrity of the data for reporting.
- Provide support in data quality checks, debugging, and resolving issues.
Leadership & Mentoring:
- Lead programming efforts and mentor junior programmers.
- Provide expertise and guidance to the team on complex programming issues and statistical methodology.

Qualifications:

Experience:
- Minimum 10+ years of programming experience, with a strong focus on ADaM and TFL programming.
- Extensive experience in Oncology/Immunology studies, particularly with Efficacy ADaMs and TFLs (ADTTE, PFS, OS, DOR, BOR, ORR).
- Expertise in generating statistical plots such as Kaplan-Meier, Waterfall, and Forest plots.
- Experience in Phase 2 and Phase 3 clinical trials is preferable.
Skills:
- Proficient in SAS, R, and other relevant statistical programming languages.
- Strong understanding of clinical data, statistical methodologies, and regulatory requirements (FDA, EMA, etc.).
- Experience working with clinical trial datasets and the ability to perform high-level data manipulation and analysis.
- Excellent problem-solving, communication, and collaboration skills.

What We Offer:

Opportunities to work with cutting-edge technology and be part of a global team.
Competitive salary and benefits package.
Professional development opportunities within a leading global clinical research company.

Equal Opportunity Employment:
IQVIA is an equal opportunity employer, committed to fostering a diverse and inclusive workforce. We provide equal employment opportunities for all, including veterans and candidates with disabilities.

For more information, visit IQVIA Equal Opportunity.

COVID-19 Vaccination Requirement:
IQVIA may require employees to meet specific COVID-19 vaccination status requirements. For more details, visit COVID-19 Vaccine Status.

Apply Now to join our dynamic team and contribute to advancing healthcare worldwide!

Latest Jobs

Associate Director - Medical Science Liaison- Neuroscience- Virginia / Washington / Maryland Region

Lilly

Richmond Hill

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Denver |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | United States |

United States :

Hawai | Sylmar |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Latvia | Leuven | Poland | Spain |

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Australia

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Richmond Hill | North York | Uxbridge | Mississauga |

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

South Yorkshire :

Sheffield |

United Kingdom :

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Attica :

Athens | Koropi |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Netanya | Be'Er Sheva | Kfar Saba | Tel Aviv |

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

Midrand |

Brazil :

Sao paulo |

South America :

Argentina |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Principal Stat Programmer

Job Description

Latest Jobs

Associate Director - Medical Science Liaison- Neuroscience- Virginia / Washington / Maryland Region

Pharmacovigilance Manager

Research Associate/ Senior Research Associate

Assoc Medical Data Review Mgr

Pharmacovigilance Services Associate

Senior Manager - Medical Affairs Professional - Obesity

Medical Affairs Professional - Oncology (Medical Advisor)

Medical Science Liaison - Biomedicines

Alliance Diabetes & Obesity Crp

Sr. Manager/Manager Medical Scientific Liaison - Oncology