Senior Director, Biostatistics

Location:  This position may be performed remotely with travel to the Boston area as needed.

The Opportunity

Reporting to the Vice President, Data Sciences, the Senior Director of Biostatistics will oversee biostatistics activities for all clinical programs across the Praxis portfolio to ensure timely and accurate delivery of statistical designs, analyses, reports, and regulatory submissions. They will independently provide strategic statistical input to drug development, including feasibility assessments, development plans, complex study designs, interpretations, and follow up. This person will work closely with the Clinical Development team, including Clinical Operations, Clinical Pharmacology, and Regulatory functions to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. Represents Biostatistics in core project teams on all applicable operational and strategic decisions related to assigned projects. This individual is also accountable for the review, approval, production and validation of biostatistics deliverables and managing internal/ external statisticians.

Primary Responsibilities

• Provides statistical leadership and support for all activities related to clinical development, including development of key study and program hypotheses, clinical development plans, study designs, regulatory meetings, submissions, and follow up.
• Applies fit for purpose and when relevant, innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and/or Bayesian approaches).
• Ensures accurate, statistically valid deliverables in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.
• Coordinates simultaneous achievement of major statistical deliverables and milestones for multiple clinical trials across the Praxis portfolio in collaboration with the clinical development team and other functions.
• Leads and manages internal/external biostatistics resources supporting studies and programs. Collaborates with data management and statistical programming to provide timely and accurate biostatistics deliverables.
• Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.
• Responsible for providing statistical input and leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies.
• Collaborates with Data Management and Statistical Programming to build our internal capabilities and develops standard processes for CDISC compliant data sets (SDTM and ADaM), performing formal tables, listing & figure production and QC in preparation for submission readiness.

Qualifications and Key Success Factors

• PhD in Biostatistics/Statistics or equivalent with a minimum of 10 years relevant work experience or MS in Biostatistics/Statistics or equivalent with a minimum of 15 years relevant experience.
• Extensive experience with IND/NDA activities and regulatory interactions, including filing, ISS and/or ISE experience.
• Experience with interim analysis design, conduct and manage/support data monitoring committee.
• Broad knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas.
• Excellent SAS programming and analytical skills to develop programs to QC, using SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macros. Ability to do simulations in a programming language such as SAS or R.
• Knowledge of GCP/ICH guidelines for conducting clinical trials.
• Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially the FDA.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc.
• Able to manage multiple projects and conflicting priorities, and to be flexible when priorities change.
• Effective team player with willingness to go the extra distance to deliver results, meet/exceed deadlines, etc.
• Strong ability to motivate staff and ensure productivity and smooth operation in conditions with ambiguity.
• REQUIRED:  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices.

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Company Overview 

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.  At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.  Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE^® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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