Remote (UAE) Research Manager

About ResearchGuru

RG provides biostatistical services to advance the development of new drugs, biologics, and devices, including strategic statistical consulting. We are focused on the design and analysis of clinical trials, but also have experience with epidemiology studies and patient registries.

About the job

Job Title: Research Manager – Premarket Tobacco Application

Location: [Dubai, UAE] (Hybrid/Remote options may be considered)

Job Summary:

We are seeking a highly motivated and experienced Research Manager to lead and execute research activities related to Premarket Tobacco Applications (PMTAs). This critical role will be responsible for the design, implementation, and analysis of epidemiological and statistical studies to support PMTA submissions to the FDA. The ideal candidate will possess a strong background in statistics and epidemiology, coupled with experience in the tobacco/nicotine industry and regulatory processes.

Responsibilities:

1. Lead the development and execution of research strategies for PMTA submissions, including clinical studies, epidemiological studies, and other relevant scientific investigations.
2. Design and analyze epidemiological studies to assess the potential health effects of tobacco products.
3. Apply advanced statistical methods to analyze complex datasets and generate meaningful insights for PMTA submissions.
4. Collaborate with cross-functional teams, including regulatory affairs, product development, and marketing, to ensure alignment of research activities with overall business objectives.
5. Manage external research vendors and consultants, ensuring projects are completed on time and within budget.
6. Prepare and review scientific documents for PMTA submissions, including study protocols, statistical analysis plans, and clinical study reports.
7. Stay abreast of current regulatory requirements and scientific advancements related to PMTAs and the tobacco/nicotine industry.
8. Present research findings to internal and external stakeholders, including regulatory agencies.
9. Contribute to the development of best practices for PMTA research and submissions.
10. Mentor and supervise junior research staff (if applicable).

Qualifications:

1. Advanced degree (Ph.D. or Sc.D.) in Epidemiology, Biostatistics, or a related field.
2. Minimum of 4 years of experience in epidemiological and statistical research, preferably within the tobacco/nicotine industry or a related regulated industry (e.g., pharmaceuticals, medical devices).
3. Demonstrated expertise in designing and analyzing epidemiological studies, including cohort studies, case-control studies, and cross-sectional surveys.
4. Strong proficiency in statistical programming languages (e.g., SAS, R) and statistical modeling techniques.
5. Experience with PMTA submissions and FDA regulatory requirements is highly preferred.
6. Excellent written and verbal communication skills, including the ability to clearly and concisely present complex scientific information.
7. Strong project management skills and the ability to manage multiple projects simultaneously.
8. Ability to work effectively in a cross-functional team.
9. Strong analytical and problem-solving skills.
10. Knowledge of tobacco/nicotine products and related health issues is a plus.

Benefits:

550,000 UAE Dir

To Apply:

Please submit your resume and cover letter. In your cover letter, please highlight your experience in statistics, epidemiology, and your experience with PMTA submissions or other regulatory experience.