Director, Biostatistics

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 millionin funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

The Director, Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic area. This individual must possess the ability to design and execute a variety of specialized and complex global development projects, in-depth knowledge of clinical design of experiments, and ability to interpret results to team members. The Director, Biostatistics would supervise the activities of contract biostatisticians, including resource allocation, directing the scheduling of work assignments, and monitoring project status to assure timely completion of projects. This person should be highly motivated and should stay current on new developments and technological advancement in statistics. The Director, Biostatistics will be responsible for partnering with scientists in Clinical, Pharmacovigilance, Translational Medicine, Regulatory, and Clinical Pharmacology on late stageclinical development projects, and will be accountable for the statistical integrity, adequacy, and accuracy of their assignments.

Here's how you will contribute:

• Serve as a key statistical leader guiding clinical development strategies and regulatory submissions, acting as a subject matter expert in statistical design and methodology while driving cross-functional alignment on statistical strategy.

• Represents Biostatistics at Project and Study team meetings. Interacts with Clinical Development, Regulatory Affairs, Statistical Programming, Data Management, Translational Medicine, Clinical Pharmacology, Clinical Operations and others to design clinical trials, as well as ensure the clinical program is well executed through appropriate analyses.

• Analyze data and interpret results from clinical trials to meet the project objectives; may work on exploratory analyses related to clinical pharmacokinetic/pharmacodynamic, translational biomarker, and/or manufacturing data.

• Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management.

• Apply and implement basic and complex statistical techniques independently to assigned projects.

• Assist in the oversight of data flow and transfers to ensure timing and quality of data collection as well as data reporting.

• Work with Statistical Programming to ensure programs meet analysis requirements, internal SOPs, and external regulatory requirements.

• Oversee the activities of statistical service providers, as appropriate.

• Serves as an SME in the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.

• Identifies the need for new process improvement initiatives, and leads working groups to solve the process gaps. Sets timelines and expectations for the deliverables.

• Identifies the need for new statistical methodology and keep abreast of new developments in statistics, drug development, and regulatory guidance to establish required methodology.

The Ideal Candidate will have:

• PhD or equivalent degree in statistics/biostatistics with >8 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >10 years’ experience.

• Prior statistical leadership or significant contribution to at least one late stage (Phase 2b and beyond) study

• Some experience in Covid/vaccine/respiratory immunology and/or oncology therapeutic arearesearch and development is preferred.

• Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.

• Capability to provide statistical leadership to cross-functional teams at the protocol and project level.

• Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.

• Expertise in statistical software such as R or SAS is required

• Deep knowledge of statistical methodologies for clinical trial designs, including adaptive, Bayesian, and platform trials, and analysis of various types of endpoints data.

• Skilled in clinical trial simulations, including designing and interpreting complex simulation studies.

• Providing statistical support and oversight for one or more clinical projects.

• Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-statistical and statistical audiences.

• Driven for results with demonstrated interest and ability to welcome new challenges, embrace changes, take initiative, and find solutions to technical problems.
• Demonstrated ability and interest to learn multiple disease indications, endpoints and appropriate statistical/regulatory requirements.

Preferred Experience:

• Successful contribution to regulatory submissions (e.g., BLA, MAA) and interactions with health authorities.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

COVID Safety:

Generate:Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster. The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations. The Company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.