Senior Statistical Programmer (Poland)

7+ years

Not Disclosed

Poland

10 Nov. 24, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences/ B.sc/ IT/ B.tech/B.ca 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

Senior Statistical Programmer - Innovaderm (Remote, Poland)

Overview
The Senior Statistical Programmer at Innovaderm will lead multiple clinical trials, managing the development, maintenance, and validation of annotated Case Report Forms (aCRFs), SDTM datasets, ADaM datasets, and Tables, Listings, and Figures (TLFs). The role will involve collaborating with biostatistical teams, supporting data cleaning, and ensuring compliance with industry standards, such as CDISC, ICH, and regulatory requirements. The Senior Statistical Programmer will also work to improve internal processes and increase efficiency in statistical programming activities.

Responsibilities

Programming and Data Management

Lead programming efforts on multiple clinical trials, ensuring timely and high-quality deliverables.
Review the statistical programming scope and budget at the initiation of trials to identify out-of-scope tasks.
Support Data Management (DM) teams with data cleaning activities, including programming and closing statistical data issues.
Develop, maintain, and validate (as needed) aCRFs and statistical programming specifications for SDTMs, ADaMs, and TLFs.
Ensure SDTMs, ADaMs, and define.XMLs comply with CDISC guidelines and Innovaderm/Sponsor standards.
Use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs, addressing any findings with the Statistical Programmer or Lead Biostatistician.
Create and maintain global SAS macros to increase programming efficiency for SDTMs, ADaMs, and TLFs.
Act as the Unblinded Primary or QC Statistical Programmer for randomization plans, interim analyses (IAs), and Data Monitoring Committee (DMC) data reviews.

Quality and Process Improvement

Identify and contribute to internal initiatives to improve efficiency and quality in statistical programming, such as the development and validation of standard macros and templates.
Stay updated with the latest industry standards, including ICH, CDISC, and regulatory authority guidelines.
Mentor junior Statistical Programmers and provide guidance on best practices and industry standards.

Collaboration and Communication

Collaborate with biostatistical study teams and cross-functional departments to produce deliverables within timelines and budgets.
Communicate effectively with internal and external stakeholders, including the Sponsor, to ensure alignment on project goals and timelines.
Participate in internal initiatives and contribute to improving the statistical programming processes.

Requirements

Education

Bachelor’s degree in Statistics, Computing Sciences, or a related field; Master’s degree is an asset.

Experience

At least 7 years of experience in clinical research within the biotechnology, pharmaceutical, or CRO industry.
Minimum of 5 years in Statistical Programming, with at least 2 years as a Lead Statistical Programmer.

Skills and Knowledge

Strong knowledge of clinical trial data, SAPs, TLF Shells, and specifications.
Excellent working knowledge of SAS; SAS certification is an asset.
Proficiency in XML programming is a plus.
Familiarity with CDISC standards and guidelines; CDISC certification is an asset.
Knowledge of drug development processes and ICH guidelines (including E6, E9, E9(R1)) as well as relevant Health Canada and FDA regulations.
Strong organizational skills, with the ability to manage multiple projects in a fast-paced environment.
Ability to work independently and in team settings, with strong communication skills (verbal and written) in English.

Why Innovaderm?

Work Environment
At Innovaderm, you'll join a collaborative and innovative team. We value reliability, responsiveness, and continuous improvement. The company offers a dynamic and supportive work environment, as well as ample opportunities for professional growth.

Benefits

Permanent, full-time position.
Flexible work schedule and home-based role.
Ongoing learning and development opportunities.
Competitive compensation and vacation benefits.

Work Location

This role is remote-based within Poland. As the company operates across multiple time zones, flexibility in working hours is required to accommodate global team and client meetings.

About Innovaderm

Innovaderm is a Contract Research Organization (CRO) specializing in dermatology. With a solid reputation for excellence, Innovaderm has been providing high-quality research and services to exceed client expectations since 2000. Headquartered in Montreal, Innovaderm continues to expand its footprint in North America and Europe.

Commitment to Equity
Innovaderm is committed to providing equitable treatment and equal opportunities for all individuals. We provide accommodations throughout the recruitment process for applicants with disabilities upon request.

Note
Innovaderm only accepts applicants who are legally eligible to work in Poland.

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 :

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 :

Uxbridge | North York | Richmond Hill | 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 :

Koropi | Athens |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

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

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 |

Senior Statistical Programmer (Poland)

Job Description

Senior Statistical Programmer - Innovaderm (Remote, Poland)

Responsibilities

Programming and Data Management

Quality and Process Improvement

Collaboration and Communication

Requirements

Why Innovaderm?

Work Location

About Innovaderm

Latest Jobs

Medical Coder

Hospital Pharmacist

Principal Statistical Programmer

Senior Principal Biostatistician

Associate Director - Pks Drug Disposition, Hyd

Tco Physician

Director - Pks Gh Ta Lead

Medical Director Ii

Clinical Operations Specialist

Analyst, Global Stability