Statistician III

Minimum Requirements:

• Master’s degree in Statistics or related field +8 years’ experience or PhD in Statistics or related field +6 years ‘experience.

• Proficient in SAS programming, able to conduct analyses without programming support, and familiar with at least some other significant statistical software (e.g., S-Plus, PASS).

• Basic knowledge of regulatory guidance documents such as ICH guidance’s.

• Demonstrated written and oral communication skills.

• Ability to work independently.

RESPONSIBILITIES:

Statistician working and training on post-hoc analyses, publications, trial design and reporting activities with minimal review. Statistics representative for cross-functional teams and for review within Biostatistics & Programming, Clinical Development Operations, and Therapeutic Areas.

PRINCIPAL RESPONSIBILITIES:

1. Leads statistical input for at least one disease indication, including review within Biostatistics & Programming, Clinical Development Operations, and Therapeutic Areas.

2. Leads clinical study design.

3. Leads analysis planning for clinical studies, post-hoc analyses and publications.

4. Leads statistical input to clinical study reports.

5. Provides statistical support to other disciplines associated with clinical statistics.

6. Serves as a primary contact with outside investigators in the preparation of scientific presentations and manuscripts.

7. Takes a leadership role in process improvement, training, standards development or an area of technical expertise.

PRINCIPAL RELATIONSHIPS: Biostatistics staff; Clinical Teams and associated working groups

Contacts Inside the Company: Therapeutic area scientific staff; SAS Programming; Clinical Database Management; Clinical Trials Management; Regulatory Affairs; Clinical Communications; Marketing; Clinical Pharmacology; Medical Writing, Quality Management

Contacts Outside the Company: Key opinion leaders; CRO staff; Regulatory Agencies; External trial committees; Advisory boards