Job Title: Principal Statistical Programmer FSP
Location: Remote, Pune, Maharashtra, India
Job Type: Full-time
Posted: Feb. 14, 2025
Job ID: 443
Position Overview:
The Principal Statistical Programmer will work independently with minimal supervision, playing a pivotal role in clinical development programs across various therapeutic areas. You will be responsible for implementing reporting and analysis activities for sponsor clinical trials, as well as overseeing CRO programmers to ensure high-quality and timely data summaries. This role requires an expert in statistical programming who can also provide technical support to team members.
Responsibilities:
Generate SDTM, ADaM specifications, datasets, reviewer’s guide, and define.xml files for multiple studies.
Develop SAS programs to generate datasets, complex listings, tables (including descriptive and inferential statistics), and complex graphs in collaboration with statisticians.
Deliver high-quality statistical programming results, developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs.
Oversee CRO’s statistical programming deliverables to ensure high quality and adherence to timelines.
Support the preparation of clinical study reports, regulatory submissions, publications, and exploratory analyses.
Follow FDA regulations for reporting clinical trial data, including good clinical practices and guidelines for electronic submissions.
Contribute to the creation, maintenance, documentation, and validation of programming standards.
Collaborate with internal and external functions (e.g., CROs, software vendors, clinical development partners) to meet project timelines.
Contribute to the review and creation of SOPs and work instructions for statistical programming practices.
Qualifications:
Education: At least a Bachelor’s degree in Computer Science, Data Science, Mathematics, Statistics, or a related field.
Experience:
7+ years of experience as a Statistical Programmer in a Biotech/Pharma Clinical Development Biometrics Team or similar team, supporting drug development or intervention studies.
Exceptional SAS programming skills with expertise in statistical programming procedures and processes in a clinical development environment.
Extensive experience with CDISC standards (SDTM, ADaM, Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations.
Experience supporting regulatory submissions and interacting with global regulatory authorities such as the FDA.
Must be able to work independently with excellent communication and leadership skills.
Preferred Qualifications:
Experience with pharmacokinetic data and neuroscience.
Proficiency in programming languages/tools other than SAS (e.g., R, Python, Java, Shiny, Markdown, Unix/Linux, Git).
Additional Information:
Location: Remote (Pune, Maharashtra, India).
Cytel is committed to staff development, innovation, and collaboration in advancing clinical development.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |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 :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Jakarta |East Java :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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New Mexico | Ciudad de México |Dubai :
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Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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