Job Summary

Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design, follow and execute statistical analysis plan and helps in interpretation of results with supervision. This position contributes to specific aspects of drug development plans with supervision and contributes to documents submitted to Health Authorities globally with supervision. This position also works on statistical methodology and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal programmers in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams. This position works under supervision to solve complex study problems.

Responsibilities

Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR):

• Executes statistical activities for low to medium complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, data surveillance review, statistical analysis accuracy validation, results interpretation and CSR input and review.
• Acts as main statistical contact for the assigned studies and projects.
• Provides guidance to study team on all aspects of statistical activities.
• Works closely with statistical programmers in statistical analyses execution, quality control, and data derivation. 
• Collaborates closely with data manager to ensure high quality data.

Global strategy to Improve Drug Development:

• Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.

CRO / Vendor Oversight:

• Review CRO/vendor proposal and budget. Set expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies.
• Ensures deliverables are accurate and delivered according to the timelines.

Global Health Authority Interaction / Negotiation:

• Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities

Qualifications

Education Qualifications
Minimum 3 years experience with a Master Degree in statistics or biostatistics. required

Minimum 0- 2 years relevant experience in the pharmaceutical industry with Ph.D. in statistics or biostatistics or equivalent field. Ph.D. is strongly preferred.

Experience Qualifications
Strong knowledge of statistical methodologies.
Some understanding of current drug development trends and regulatory environments.
Sufficient programming skills in SAS and/or R and working knowledge of software such as nQuery, East, etc.
Strong analytical and problem-solving skills.
Some knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation.
Excellent oral and written communication skills in English.
Ability to identify and investigate issues and causes and formulate potential solutions with supervision.
Ability to prioritize multiple tasks, develop instructions and manage vendors and collaborate with internal programming colleagues in completing the deliverables with high quality according to timelines, and provide recommendations to improve process.
Compliant with internal and external compliance practice to ensure integrity of work and suggest innovative approaches to improve compliances and processes.
Some knowledge of clinical trial methodologies.


Travel Requirements
Ability to travel up to 10% of the time.