Principal Statistician - Early Development

3-5 years

Not Disclosed

Remote

10 June 28, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Company Overview: Cytel Software Corporation

At Cytel, we work hard to create successful careers with significant professional growth for our employees, resulting in our employees working hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.

Job Description: FSP Biostatistician

Responsibilities:

Independently lead the development and execution of statistical aspects for studies of moderate complexity.
Participate in PRC (Protocol Review Committee) reviews of study protocols and SAPs.
Provide data interpretation for study documents such as CSR.
Participate in statistical organization continuous improvement initiatives.
Be a member of cross-functional development teams and contribute to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.
Have responsibilities for integrated summaries and/or supporting a particular indication of an asset.
Develop collaborative relationships and work effectively with the GBS (Global Biometric Sciences) Biostatistics Lead, clinical trial manager, medical monitor, clinical scientist, data manager, PK scientist, and other members of the study/indication team.
Make strategic and scientific contributions at the indication/protocol/integrated analysis level.
Drive the selection of optimal study designs, data collection, analytic approaches, and rigorous interpretation of trial data.
Interact with external vendors, key opinion leaders, and regulatory agencies as necessary.

Qualifications and Experience:

Master’s degree in Statistics or equivalent with ≥ 5 years of industry-related experience OR Ph.D. in Statistics or equivalent with ≥ 3 years of industry-related experience.
Demonstrated knowledge of statistical/clinical trials methodology as it relates to clinical development.
Strong experience with sample size calculation and protocol design.
Experience with any of the following: food effect, drug-drug interaction, dose proportionality, special populations (renal impairment, hepatic impairment, elderly population) with some BA/BE (bioavailability/bioequivalence) and ADME (Absorption, Distribution, Metabolism, and Excretion).
Relevant prior data analysis planning, execution, and delivery experience.
Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals.
Excellent verbal and written communication skills.
Flexibility and ability to adapt quickly to the changing needs of the organization.
Ability to organize multiple work assignments and establish priorities.
Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.

Preferred Experience:

Therapeutic Area (TA) experience: Oncology, Cardiology, Immunology, Hematology, Neurology.
Phase experience: Heavy Phase 1, some Phase 2.
Ability to overlap working hours from 8am-11am EST.

Additional Information:

Cytel Inc. is an Equal Employment / Affirmative Action Employer.
Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Cytel does not accept referrals from employment businesses and/or employment agencies for the vacancies posted on this site.
All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel.
The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/agency and Cytel.
In the absence of such written authorization, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall, therefore, not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

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