Snr Manager & Associate Director roles in Biostatistics** Support multiple TA’s (including Oncology) for early & late stage dev. + NDA/BLA's ** Boston, MA

Location

Suffolk, VA | United States

Job description

Job Description

Snr Manager & Associate Director roles in Biostatistics** Support multiple TA’s (including Oncology) for early & late stage dev. + NDA/BLA's ** Boston, MA

Our client is a highly successful research-based bio-pharmaceutical company who are leaders in developing and commercializing Rare Disease indications. They have a strong pipeline across all stages of development for multiple TA’s (including Oncology) and they are continually recognized (and rewarded) for being one of the best companies to work for on the East Coast, where they have offices in multiple locations including Boston and Southern Connecticut. They are financially strong and unlike many other companies at the moment, they are growing and recruiting and not making redundancies!

Due to the successful expansion of their early development pipeline, they are now recruiting for both Senior Manager & Associate Director grades in Biostatistics. Interested candidates will need to have a comprehensive knowledge of statistical methodology in the design and analysis of clinical trials (i.e. Bayesian modeling, adaptive designs) and want to work for an organization committed to the Rare Disease Community with a strong focus on Oncology, Neurology and Hematology projects.

For the senior manager grade, you will find this is a career role, where you can develop and grow in a rewarding and friendly environment, and for the Associate Director grade, you will have the opportunity to matrix manage a team and be accountable for the production of biostatistics deliverables.

For both roles, you will work collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials and serve as the study level biostatistician including participating in study design and protocol review discussion. You will ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents and coordinate the achievement of major statistical deliverables and milestones in collaboration with other functions.

Responsibilities will change according to your level / grade but will include the following:

• Providing statistical support to clinical development through the design and conduct of multiple clinical studies through all stages of development (P1-P3 and NDA/BLA) across several therapeutic areas including Oncology, Neurology and Metabolism.
• Participating in cross-functional protocol design and review discussions, and supporting protocol development to ensure appropriateness of trial design, sample size, and statistical methodologies.
• Co/Lead the development of statistical analysis plan, data presentation plan, DMC charter, and other relevant documents by collaborating with cross-functional partners to meet project timelines.
• Reviewing the accuracy/consistency of clinical data and statistical outputs, performing ad-hoc statistical analysis, interpreting study results, and collaborating with cross-functional partners to produce interim reports, final reports, scientific publications, and internal/external presentations.
• Collaborating with clinical operations, data management, statistical programming and CRO to develop and implement CRFs, database design, and the overall data quality plan.
• Reviewing vendor data transfer specifications and ADaM programming specifications
• Evaluating and managing CROs and other vendors, including scope-of-work, timelines, deliverables and budgets.

Packages for both role are competitive for the East Coast and include a strong salary, higher than average bonus, and a generous stock package. Relocation packages are also available for those who need it.

For the Associate Director role, you will need:

• Ph.D. (8+ years’ experience ) or MS (10+ years’ experience ) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.

For the Senior Manage role, you will need:

• Ph.D. (4+ years’ experience) or MS (6+ years’ experience ) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience

To Apply!

If you are interested in applying or would like to hear more about this position, press the “Apply Here” button or please contact Theo Moore via email at [email protected] call directly at 587.216.9302.

We look forward to hearing from you!

LinkedIn: https://ca.linkedin.com/in/theo-moore-b33696a

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