Job Title: Associate Director, Biostatistics
Location: Remote (India, Poland, South Africa)
Job Type: Full-time
Posted: Dec. 18, 2024
Job ID: 292
Job Overview:
As an Associate Director, Biostatistics at Cytel, you will lead statistical activities in support of Immunology or Oncology therapeutic areas. Your work will involve study design, protocol and analysis plan development, and conducting ad hoc and exploratory analyses. You will play a key role in providing statistical leadership and expertise in clinical development projects, working closely with cross-functional teams to deliver high-quality statistical outputs.
Responsibilities:
Lead statistical teams, ensuring timely delivery of statistical outputs aligned with project goals.
Provide statistical input into clinical development plans, concept sheets, and protocols.
Contribute to study protocols, case report forms (CRFs), data management plans, and statistical analysis plans (SAPs).
Review and contribute to study reports and regulatory submission dossiers, including electronic submissions to regulatory authorities.
Manage biostatisticians and statistical programmers when in the lead role, ensuring alignment of statistical strategy and deliverables.
Drive innovative statistical methodologies and contribute to the development and visibility of the company’s expertise.
Collaborate and communicate effectively with sponsor cross-functional teams and sponsor biostatistics management.
Qualifications:
Education: Ph.D. or MS in Statistics, Biostatistics, or a related discipline.
Experience:
At least 6 years of experience as a biostatistician in the pharmaceutical/biotechnology industry.
At least 3 years as a Lead Biostatistician for clinical development projects.
Skills:
Knowledge of international regulatory guidelines and experience with regulatory interactions and electronic submissions (e.g., to FDA).
Working knowledge of SAS and CDISC.
Strong leadership and mentoring abilities.
Fluent in English (French or German is a plus).
Ability to work effectively in international teams and matrix organizations.
Excellent time management, communication, and problem-solving skills.
Additional Information:
Location: Remote work available in India, Poland, and South Africa.
Cytel values the development of its employees and supports continuous learning and career advancement.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
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Stirling | United Kingdom | Leeds | Salt Lake City | London | Stevenage | England | Harlow | Maidenhead |Estonia :
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Remote - Middle East | Switzerland | Remote - Africa | Remote - South America (Latin Americal) | Remote | Remote, USA | Remote - Europe |Bucharest :
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Riyadh | Najran | King Abdullah Economic City | Rabigh | Jeddah | Khulais |Nišava District :
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