We are looking for two experienced statistical programmers for our pharma client, this is a remote position.

Job Summary

Statistical Programming Contractor will provide oversight of CRO statistical programming activities and/or collaborate closely with other functions in the project team. Hands-on support to internal company teams and technical abilities to enable process improvements surrounding Statistical Programming will be needed, as well as hands-on support to all clinical development programs and regulatory submissions.

Roles & Responsibilities may include, but not be limited to:

1. Serve as statistical programming representative in study management teams and related regulatory interactions

2. Collaborate with biometrics and clinical development teams in building data and analysis standard

3. Ensure quality of all statistical programming deliverables

4. Review study protocol, CRF, SAP, DTAs, TFL shell and other study documentations

5. Perform / review / QC ADaMs and TFLs to ensure quality and accuracy

6. Work with Statisticians on exploratory analyses of existing data, and ongoing data query and review

7. Contribute to statistical programming deliverables for regulatory submissions

8. Develop and maintain necessary programming macros or tools to effectively support all programming needs

9. Support statistical analyses, clinical study reports, IB, regulatory related documents, publications, and scientific presentations, and perform QC activities accordingly

10. Support cross functional activities related to biometrics and clinical program development as needed

11. Other duties that may be assigned.

Supervision

Position does not have supervisory responsibilities.

REQUIREMENTS & WORKING CONDITIONS

Education & Licenses and Experience

Typically requires bachelor’s degree in computer science, statistics, or related fields and 7+ years of experience in pharmaceutical / biotechnology companies; a master’s degree related to the position may be substituted for some years of experience. Experience as a study lead programmer and / or overseeing CRO performance is required.

Competencies & Skills

· Ability to work in a fast-paced, dynamic environment with little supervision

· Expert in SAS with extensive knowledge in CDISC including SDTM, ADaM, RG, Pinnacle 21, and controlled terminologies

· Ability to prioritize and manage multiple priorities and responsibilities simultaneously and follow-through on issues in a timely manner

· Working knowledge of EDC and common Data Management applications and knowledge of other external data sources

· documentations including protocol, CRF, DTA, SAP, DDT and TFL specification

· Familiar with ICH guidelines, GCP regulations, FDA / EMA / other regulatory authority guidances related to Statistical Programming requirements.

· Strong collaboration skills

· Experience of working in start up companies, participation in regulatory interaction, leading regulatory submissions and participation in audit is preferred

· Abilities in R and/or Python are desirable, but not required.

Job Type: Contract

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Professional development assistance
• Tuition reimbursement
• Vision insurance

Work Location: Remote