Principal Biostatistician (Heor/Hta)

0-2 years

Not Disclosed

Columbia Remote, USA

10 Feb. 7, 2025

Job Description

Job Type: Full Time Education: Graduate degree in biostatistics or a related field. 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: Principal Biostatistician (HEOR/HTA)

Location: Colombia, Latin America (Client-Based)

Job ID: 25001623

Date Updated: February 5, 2025

Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs, and commercial insights into outcomes to meet modern market demands. With a focus on putting customers and patients at the center, Syneos Health aims to simplify and streamline processes to foster collaboration and drive success in clinical development.

With over 29,000 employees across 110 countries, Syneos Health strives to create an inclusive and supportive environment for its global workforce.

Job Responsibilities

Leadership & Mentorship:
- Act as a resource for the statistical department.
- Mentor biostatisticians, develop and deliver training sessions, and enhance skills for existing personnel.
Project Oversight:
- Manage and direct biostatistics personnel on assigned projects to ensure high-quality work is delivered on time.
- Provide independent review of work produced by other biostatisticians.
Statistical Analysis:
- Provide statistical support across all stages of the project lifecycle (from protocol to CSR).
- Oversee or prepare Statistical Analysis Plans (SAPs) and collaborate with sponsors if required.
- Create and review programming specifications for analysis datasets, tables, listings, and figures.
Quality Assurance:
- Review SAS annotated CRFs, database designs, and study documentation to ensure data capture meets protocol requirements.
- Conduct and participate in verification and quality control of project deliverables.
Project Management:
- Oversee scheduling and time constraints across multiple projects, adapting to timeline changes.
- Ensure milestones are met and escalate out-of-scope tasks to management.
Regulatory and Business Development:
- Attend regulatory meetings and provide statistical analysis support as needed.
- Contribute to proposals, budgets, and sponsor bid defense meetings.

Required Qualifications

Experience:
- Previous experience in HEOR (Health Economics and Outcomes Research) and/or HTA (Health Technology Assessment) is required.
- Extensive experience in clinical trials, including leading multiple projects.
Education:
- Graduate degree in biostatistics or a related field.
Skills:
- Strong proficiency in statistical programming.
- Deep knowledge of statistical design and analysis techniques used in clinical research.
- Excellent written and verbal communication skills in English.
- Ability to effectively communicate statistical concepts and regulatory guidelines.

Additional Qualifications

Experience with regulatory submissions is preferred.
Ability to lead complex projects and interact with various departments to achieve business goals.

About Syneos Health

Syneos Health has contributed to 94% of all novel FDA-approved drugs and 95% of EMA-authorized products over the past five years. With extensive experience across 73,000 sites and 675,000+ trial patients, Syneos Health plays a vital role in accelerating the delivery of life-changing therapies.

Why Work with Us?

Career Development: We are committed to your growth through continuous learning, technical training, and career progression opportunities.
Inclusive Culture: Our Total Self culture celebrates diversity, making Syneos Health a place where everyone feels they belong.
Global Impact: Contribute to cutting-edge projects that influence healthcare outcomes worldwide.

Additional Information

Minimal travel may be required.
Applicants must be located in or be eligible to work in the listed regions (UK, Ireland, Greece, Hungary, Poland, Romania, South Africa, Spain, Ukraine, Argentina, Brazil, Colombia, and Mexico).
The company reserves the right to assign additional responsibilities as needed.
Syneos Health adheres to the Americans with Disabilities Act and complies with all relevant local employment regulations.

Apply Now or Join Our Talent Network to stay connected with future opportunities!

Latest Jobs

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 :

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh | Roorkee |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

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 | Ft MItchell | 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 | Virginia |

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 | Oeiras | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | OH | United States |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

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

Belgium :

Wavre |

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China | Quarry Bay |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Australia

Melbourne :

South Yarra |

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

North Brabant :

Breda |

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 & New Zealand & Peru & 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 |

Flemish Brabant :

Zaventem |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

Oxfordshire :

Witney |

South Yorkshire :

Sheffield |

United Kingdom :

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Attica :

Koropi | Athens |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

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 |

North Island :

Auckland |

Lima Region :

Lima |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

South Africa | Midrand |

Brazil :

Brazil | Sao paulo |

South America :

Peru | 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 Biostatistician (Heor/Hta)

Job Description

Company Overview

Job Responsibilities

Required Qualifications

Additional Qualifications

About Syneos Health

Why Work with Us?

Additional Information

Latest Jobs

Quality-Medical Affairs Professional

Medical Writing – Medical Affairs

Quality Medical Reviewer – Medical Affairs Quality

Specialist - Medical Editor

Specialist - Quality Operations (Gqs I)

Patient Safety Specialist

Global Medical Development Manager