Job Description
Job Details
Job Location Main Corporate Office - Malvern, PA
Description Job Purpose: The Principal Biostatistician is a key member of Ocugen's clinical development team. This individual will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods given the hypothesis and available data through programming in SAS, or R. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs of the clinical studies.
Duties and Responsibilities: - Collaborates on implementation and analysis of statistical aspects of research protocols.
- Provides statistical consultation for clinical programs.
- Performs sample size and power calculations, and provides input on Study Protocols.
- Develops statistical analysis plans, including detailed textual description of planned analysis and mock-ups of data displays.
- Assists in development of CRFs, programming specifications, and additional study documents related to data flow and analyses.
- Performs statistical analyses, including hypothesis testing and modeling.
- Provides tabular and written summaries of analyses and statistical methodology.
- Reviews and provides comments on statistical summaries.
- Interface with CRO ensuring data and statistical reporting is secure and timely.
- Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met.
- Ensures that project tasks are completed with acceptable quality.
- Attends team meetings and represents departmental needs for assigned projects.
- Participate in study and department meetings.
- May assist in developing policies and procedures (SOPs).
- Additional tasks and projects as requested.
Qualifications - MS/MA degree in Biostatistics.
- 5+ years of research experience working as Biostatistician, or Statistical Programmer
- Ability to synthesize results in graphic, oral, and written reports
- Exceptionally strong statistical programming in SAS
- Experience programming in other languages, such as R, SQL, Matlab
- Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies
- Demonstrated attention to detail and outstanding organization skills
- Self-motivated with a commitment to high quality, on-time deliverables
- Excellent communication and collaboration skills with a team-oriented approach
- Demonstrated ability to identify and resolve issues and effectively manage timelines
Working Conditions:
This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.
Physical Requirements: This is a largely sedentary role.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
Job Tags
Full time, Work at office, Local area, Remote work,