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Description:

The Principal Biostatistician/Statistical Programmer 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 and generation of accurate and reproducible results through error- free statistical programming in SAS, R and/or other programming languages. This individual will work closely with the Director of Biostatistics, the rest of the team, and CROs to execute the statistical and data needs.

Duties and responsibilities

• SAS Programming: You'll utilize advanced SAS programming skills to analyze and report clinical trial data (both safety and efficacy).

• CDISC Standards: Proficiency in CDISC standards (SDTM & ADaM) is essential. You'll generate and validate SDTM and ADaM datasets, as well as create tables, listings, and figures (TLFs).

• Study Lead: Experience juggling multiple projects simultaneously is preferred.

• Submission Documents: You'll create and review submission documents and electronic case report forms (eCRTs).

• Collaboration: Effective communication with cross-functional teams and clients is crucial.

• Assists the Sr Director of Biometrics in providing statistical consultation for clinical programs, including randomization, sample size assessments, efficacy evaluations, and data review.

• Develops statistical analysis plans, including textual descriptions of planned analyses and mock-ups of data displays.

• Provides tabular and written summaries of analyses and statistical methodology.

• Ensures accurate programming of SAS clinical data extracts and data displays.

• Develops programming specifications, including analysis datasets and tables/listings/figures.

• Supports and/or leads programming for analysis datasets, TFLs, or standard tools following standard data models or user requirements.

• Ensures the integration of data across studies in support of CSS/CSE.

• Builds, leads, and maintains programming specifications for analysis datasets using tools and methodologies.

• Supports the creation and validation of submission requirements (e.g., annotated CRF, data export files, define documents).

• Interfaces with CRO to ensure data and statistical reporting is secure and timely.

• Proactively identifies risks, developing and implementing mitigation plans as applicable.

• Participates in study and department meetings, preparing agendas and minutes, and maintaining key decision and action item logs.

• May assist study teams and departments with financial tracking and reporting, including coordination of CRO, vendor, and site contracts.

• May assist in developing policies and procedures (SOPs).

• Additional tasks and projects as requested.

• Works in a multidisciplinary study team to provide timely and quality support for the analysis and reporting of clinical trials up to regulatory approval, product launch, and annual reports.

Skills:

Biostatistics, Statistical analysis plan, cdisc, Statistics, Sas programming, SDTM, ADaM, TFL, TLF, data standards

Additional Skills & Qualifications:

• MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field

• Experience: At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry (with a bachelor's degree) or 6 years with a master's degree or above.

• Expertise: Familiarity with statistical principles, CDISC data, and standards.

• Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc.

• Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus

• SAS, (Base, Stat, Macro, graph); SAS certificates a plus 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.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.